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Guidance for industry informed consent recommendations for source plasma donors participating in plasmapheresis and immunization programs
Guidance for industry pharmacogenomic data submissions
Guidance for industry changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region Annex 4C Microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter
Guidance for industry providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling
Guidance for industry E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding catelgories
Guidance for industry stability testing, photostability testing of new veterinary drug substances and medicinal products
Guidance for industry drug master files for bulk antibiotic drug substances
Guidance for industry Q2B validation of analytical procedures, methodology
Guidance for industry acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease : developing antimicrobial drugs for treatment
Guidance for industry biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components
Guidance for industry protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators
Guidance for industry INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information
Guidance for industry M4Q, the CTD, quality
Guidance for industry use of sterile connecting devices in blood bank practices
Guidance for industry street drug alternatives
Guidance for industry influenza, developing drugs for treatment and/or prophylaxis
Guidance for industry effectiveness of anthelmintics, specific recommendations for poultry-gallus gallus
Guidance for industry E6 good clinical practice, consolidated guidance
Guidance for industry sterile drug products produced by aseptic processing, current good manufacturing practice
Guidance for industry Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue based products (HCT/Ps)
Guidance for industry dissolution testing of immediate release solid oral dosage forms
Guidance for industry use of serological tests to reduce the risk of transmission of trypanosoma cruzi infection in whole blood and blood components for transfusion and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Guidance for industry S2B genotoxicity, a standard battery for genotoxicity testing of pharmaceuticals
Guidance for industry precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their contacts
Guidance for industry Q10 pharmaceutical quality system
Guidance for industry SUPAC-MR : modified release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation
Guidance for industry class II special controls guidance document : cord blood processing system and storage container
Guidance for industry clinical data needed to support the licensure of seasonal inactivated influenza vaccines
Guidance for industry availability of licensed donor screening tests labeled for use with cadaveric blood specimens
Guidance for industry Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter
Guidance for industry genotoxic and carcinogenic impurities in drug substances and products, recommended approaches
Guidance for industry acute bacterial otitis media, developing drugs for treatment
Guidance for industry providing regulatory submissions in electronic format, general considerations
Guidance for industry collection of race and ethnicity data in clinical trials
Guidance for industry bar code label requirements, questions and answers
Guidance for industry effectiveness of anthelmintics, general recommendations
Guidance for industry 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records
Guidance for industry FDA export certificates
Guidance for industry pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance
Guidance for industry nasal spray and inhalation solution, suspension, and spray drug products : chemistry, manufacturing, and controls documentation
Guidance for industry standards for securing the drug supply chain : standardized numerical indentification for prescription drug packages
Guidance for industry stability testing for medicated premixes
Guidance for industry streamlining the donor interview process, recommendations for self-administered questionnaires
Guidance for industry labeling for combined oral contraceptives
Guidance for industry manufacturing, processing, or holding active pharmaceutical ingredients
Guidance for industry an acceptable circular of information for the use of human blood and blood components
Guidance for industry recommendations for obtaining a labeling claim for communicable disease donor screening tests using cadaveric blood speciments from donors of human cells, tissues and cellular and tissue-based products (HCT/Ps)
Guidance for industry general principles for the development of vaccines to protect against global infectious diseases
Guidance for industry revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors
Guidance for industry use of nucleic acid tests to reduce the risk of transmission of West Nile virus from donors of whole blood and blood components intended for transfusion and donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Guidance for industry source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region Annex 4B Microbiological examination of nonsterile products : tests for specified microorganisms general chapter
Guidance for industry extended release oral dosage forms, development, evaluation, and application of in vitro/in vivo correlations
Guidance for industry recommendations for donor questioning regarding possible exposure to malaria
Guidance for industry IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information
Guidance for industry nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived products
Guidance for industry advisory committees : implementing Section 120 of the Food and Drug Administration Modernization Act of 1997
Guidance for industry container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
Guidance for industry E 11 clinical investigation of medicinal products in the pediatric population
Guidance for industry recommendations for collecting red blood cells by automated apheresis methods
Guidance for industry submission of summary bioequivalence data for ANDAs
Guidance for industry acceptance of foreign clinical studies
Guidance for industry providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications
Guidance for industry IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer
Guidance for industry criteria for safety and efficacy evaluation of oxygen therapeutics as red blood cell substitutes
Guidance for industry "help-seeking" and other disease awareness communications by or on behalf of drug and device firms
Guidance for industry effectiveness of anthelmintics, specific recommendations for caprine
Guidance for industry MedWatch form FDA 3550A, mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Guidance for industry national uniformity for nonprescription drugs : ingredient listing for OTC drugs
Guidance for industry new contrast imaging indication considerations for devices and approved drug and biological products
Guidance for industry Q3A impurities in new drug substances
Guidance for industry postmarketing studies and clinical trials, implementation of section 505(o) of the Federal Food, Drug, and Cosmetic Act
Guidance for industry use of nucleic acid tests on pooled and individual samples from donors of whole blood and plasma components (including source plasma and source leukocytes) to adequately and appropriately reduce the risk of transmission of HIV-1 and HCV
Guidance for industry format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications
Guidance for industry PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance
Guidance for industry M4E, the CTD, efficacy
Guidance for industry interpreting sameness of monoclonal antibody products under the orphan drug regulations
Guidance for industry effectiveness of anthelmintics, specific recommendations for bovines
Guidance for industry dosage and administration section of labeling for human prescription drug and biological products, content and format
Guidance for industry testing limits in stability protocols for standardized grass pollen extracts
Guidance for industry eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Guidance for industry changes to an approved application : biological products, human blood and blood components intended for transfusion or for further manufacture
Guidance for industry FDA review of vaccine labeling requirements for warnings, use instructions, and precautionary information
Guidance for industry container closure systems for packaging human drugs and biologics, questions and answers
Guidance for industry brief summary : disclosing risk information in consumer-directed print advertisements
Guidance for industry estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers
Guidance for industry labeling for human prescription drug and biological products, implementing the new content and format requirements
Guidance for industry E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
Guidance for industry E2E pharmacovigilance planning
Guidance for industry product name placement, size, and prominence in advertising and promotional labeling
Guidance for industry control of Listeria monocytogenes in refrigerated or frozen ready-to-eat foods
Guidance for industry clinical studies section of labeling for human prescription drug and biological products, content and format
Guidance for industry referencing discontinued labeling for listed drugs in abbreviated new drug applications
Guidance for industry PET drug applications : content and format for NDAs and ANDAs, fludeoxyglucose F 18 injection, ammonia N 13 injection, sodium fluoride F 18 injection
Guidance for industry cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs)
Guidance for industry guidance for human somatic cell therapy and gene therapy
Guidance for industry reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997
Guidance for industry analytical procedures and methods validation, chemistry, manufacturing, and controls documentation
Guidance for industry validation of procedures for processing of human tissues intended for transplantation
Guidance for industry fast track drug development programs, designation, development and application review
Guidance for industry statistical approaches to establishing bioequivalence
Guidance for industry effectiveness of anthelmintics, specific recommendations for ovine
Guidance for industry questions and answers regarding food allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 : final guidance
Guidance for industry waiver of in vivo bioavailability studies for immediate-release soild oral dosage forms based on a biopharmaceutics classification system
Guidance for industry advisory committee meetings : preparation and public availability of information given to advisory committee members
Guidance for industry M4S, the CTD, safety
Guidance for industry M2 eCTD : electronic common technical document specification
Guidance for industry revised recommendations for donor and product management based on screening tests for syphilis
Guidance for industry clozapine tables, in vivo bioequivalence and in vitro dissolution testing
Guidance for industry Prescription Drug Marketing Act, donation of prescription drug samples to free clinics
Guidance for industry clinical data needed to support the licensure of pandemic influenza vaccines
Guidance for industry considerations for allogeneic pancreatic islet cell products
Guidance for industry changes to an approved NDA or ANDA
Guidance for industry presenting risk information in prescription drug and medical device promotion
Guidance for industry qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act
Guidance for industry M3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals
Guidance for industry classifying resubmissions in response to action letters
Guidance for industry recommendations for deferral of donors and quarantine and retrieval of blood and blood products in recent recipients of smallpox vaccine (vaccinia virus) and certain contacts of smallpox vaccine recipients
Guidance for industry providing regulatory submissions in electronic format, postmarketing indivudal case safety reports
Guidance for industry S8 immunotoxicity studies for human pharmaceuticals
Guidance for industry warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products, content and format
Guidance for industry providing regulatory submissions in electronic format, drug establishment registration and drug listing
Guidance for industry implementing a collection program for source plasma containing disease-associated and other immunoglobulin G (IgG) antibodies
Guidance for industry nonclinical evaluation of late radiation toxicity of therapeutic radiopharmaceuticals
Guidance for industry providing regulatory submissions in electronic format, content of labeling
Guidance for industry biological product deviation reporting for blood and plasma establishments
Guidance for industry adequate and appropriate donor screening for hepatitis b : hepatitis b surface antigen (HBsAg) assays used to test donors of whole blood and blood components, including source plasma and source leukocytes
Guidance for industry computerized systems used in clinical investigations
Guidance for industry drug-induced liver injury, premarketing clinical evaluation
Guidance for industry studies to evaluate the safety of residues of veterinary drugs in human food, carcinogenicity testing
Guidance for industry stability testing of new veterinary drug substances and medicinal products (revision)
Guidance for industry assessing donor suitability and blood and blood product safety in cases of known or suspected west Nile virus infection
Guidance for industry M4, the CTD, general questions and answers
Guidance for industry safety testing of drug metabolites
Guidance for industry powder blends and finished dosage units : stratified in-process dosage unit sampling and assessment
Guidance for industry ANDAs, impurities in drug products
Guidance for industry S7A safety pharmacology studies for human pharmaceuticals
Guidance for industry handling and retention of BA and BE testing samples
Guidance for industry manufacturing biological intermediates and biological drug substances using spore-forming microorganisms
Guidance for industry food-effect bioavailability and fed bioequivalence studies
Guidance for industry recognition and use of a standard for uniform blood and blood component container labels
Guidance for industry implementation of acceptable full-length donor history questionnaire and accompanying materials for use in screening donors of blood and blood components
Guidance for industry animal models : essential elements to address efficacy under the animal rule
Guidance for industry cooperative manufacturing arrangements for licensed biologics
Guidance for industry errors and accidents regarding saline dilution of samples used for viral marker testing
Guidance for industry pharmaceutical components at risk for melamine contamination
Guidance for industry stability testing of new biotechnological/biological veterinary medicinal products
Guidance for industry SPL standard for content of labeling technical Qs & As
Guidance for industry notifying FDA of fatalities related to blood collection or transfusion
Guidance for industry format and content for the CMC section of an annual report
Guidance for industry acute bacterial meningitis, developing antimicrobial drugs for treatment
Guidance for industry Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
Guidance for industry M4, the CTD, efficacy questions and answers
Guidance for industry Prescription Drug Marketing Act (PDMA) requirements, questions and answers
Guidance for industry amendment (donor deferral for transfusion in France since 1980) to "Guidance for industry, revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products"
Guidance for industry blood establishment computer system validation in the user's facility
Guidance for industry implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997, elimination of certain labeling requirements
Guidance for industry contents of a complete submission for the evaluation of proprietary names
Guidance for industry clinical pharmacology section of labeling for human prescription drug and biological products : content and format
Guidance for industry complementary and alternative medicine products and their regulation by the Food and Drug Administration
Guidance for industry testing of glycerin for diethylene glycol
Guidance for industry aerosol steroid product safety information in prescription drug advertising and promotional labeling
Guidance for industry gene therapy clinical trials, observing subjects for delayed adverse events
Guidance for industry indexing structured product labeling
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter
Guidance for industry alternate source of the active pharmaceutical ingredient in pending ANDAs
Guidance for industry accelerated approval products, submission of promotional materials
Guidance for industry single dose acute toxicity testing for pharmaceuticals
Guidance for industry S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals
Guidance for industry public availability of labeling changes in "changes being effected" supplements
Guidance for industry botanical drug products
Guidance for industry guidance on the labeling of certain uses of Lecithin derived from soy under section 403(w) of the Federal Food, Drug, and Cosmetic Act
Guidance for industry environmental assessment of human drug and biologics applications
Guidance for industry how to comply with the Pediatric Research Equity Act
Guidance for industry container closure systems for packaging human drugs and biologics
Guidance for industry S1C(R2) dose selection for carcinogenicity studies
Guidance for industry SUPAC-SS : nonsterile semisolid dosage forms : manufacturing equipment addendum
Guidance for industry Q7A good manufacturing practice guidance for active pharmaceutical ingredients
Guidance for industry effectiveness of anthelmintics, specific recommendations for canine
Guidance for industry efficacy studies to support marketing of fibrin sealant products manufactured for commercial use
Guidance for industry good pharmacovigilance practices and pharmacoepidemiologic assessment
Guidance for industry M4, organization of the CTD
Guidance for industry drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals
Guidance for industry impurities in new veterinary drug substances (revision)
Guidance for industry considerations for plasmid DNA vaccines for infectious disease indications
Guidance for industry nonclinical studies for the safety evaluation of pharmaceutical excipients
Guidance for industry 21 CFR part 11, electronic records, electronic signatures, validation
Guidance for industry consumer-directed broadcast advertisements, questions and answers
Guidance for industry possible dioxin/PCB contamination of drug and biological products
Guidance for industry addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs
Guidance for industry public health issues posed by the use of nonhuman primate xenografts in humans
Guidance for industry tropical disease priority review vouchers
Guidance for industry "lookback" for hepatitis c virus (HCV) : product quarantine, consignee notification, further testing, product disposition, and notification of transfusion recipients based on donor test results indicating infection with HCV
Guidance for industry Q1D bracketing and matrixing designs for stability testing of new drug substances and products
Guidance for industry S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals
Guidance for industry safety studies for veterinary drug residues in human food, reproduction toxicity testing
Guidance for industry effectiveness of anthelmintics, specific recommendations for porcine
Guidance for industry nonclinical safety evaluation of pediatric drug products
Guidance for industry S1B testing for carcinogenicity of pharmaceuticals
Guidance for industry information request and discipline review letters under the prescription drug user fee act
Guidance for industry revising and ANDA labeling following revision of the RLD labeling
Guidance for industry acute or chronic bacterial prostatitis, developing antimicrobial drugs for treatment
Guidance for industry integrated summaries of effectiveness and safety : location within the common technical document
Guidance for industry 180-day exclusivity when multiple ANDAs are submitted on the same day
Guidance for industry potency tests for cellular and gene therapy products
Guidance for industry liposome drug products, chemistry, manufacturing, and controls; human pharmacokinetics and bioavailablity; and labeling documentation
Guidance for industry pharmacovigilance of veterinary medicinal products, management of adverse event reports (AER's)
Guidance for industry supplemental testing and the notification of consignees of donor test results for antibody to hepatitis C virus (anti-HCV)
Guidance for industry Q8 pharceutical development
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region Annex 1 Residue on ignition/sulphated ash general chapter
Guidance for industry E2BM data elements for transmission of individual case safety reports
Guidance for industry E2B(M), data elements for transmission of individual case study reports, questions and answers
Guidance for industry how to complete the vaccine adverse event reporting system form (VAERS-1)
Guidance for industry environmental impact assessments (EIA's) for veterinary medicinal products (VMP's)-phase 1
Guidance for industry toxicity grading schedule for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials
Guidance for industry photosafety testing
Guidance for industry nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV), testing, product disposition, and donor deferral and reentry
Guidance for industry regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) : small entity compliance guide
Guidance for industry stability testing of new veterinary dosage forms
Guidance for industry characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases
Guidance for industry financial disclosure by clinical investigators
Guidance for industry Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products
Guidance for industry granularity document : annex to M4, organization of the CTD
Guidance for industry premarketing risk assessment
Guidance for industry orally disintegrating tablets
Guidance for industry noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms : recommended prescribing information for heatlh care providers and patient labeling
Guidance for industry somatic cell therapy for cardiac disease
Guidance for industry computerized systems used in clinical trials
Guidance for industry submitting and reviewing complete responses to clinical holds
Guidance for industry E9 statistical principles for clinical trials
Guidance for industry independent consultants for biotechnology clinical trial protocols
Guidance for industry exports under the FDA Export Reform and Enhancement Act of 1996
Guidance for industry revised recommendations for the assessment of donor suitability and blood product safety in cases of suspected severe acute respiratory syndrome (SARS) or exposure to SARS
Guidance for industry formal meetings between the FDA and sponsors or applicants
Guidance for industry antiviral product development, conducting and submitting virology studies to the agency
Guidance for industry incorporation of physical-chemical identifiers into solid oral dosage form drug products for anticounterfeiting
Guidance for industry the use of mechanical calibration of dissolution apparatus 1 and 2, current good manufacturing practice (CGMP)
Guidance for industry Q1B photostability testing of new drug substances and products
Guidance for industry process validation, general principles and practices
Guidance for industry IRB review of stand-alone HIPAA authorizations under FDA regulations
Guidance for industry certain human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered from donors who were tested for communicable diseases using pooled speciments or diagnostic tests
Guidance for industry NDA's : impurities in drug substances
Guidance for industry content and format for geriatric labeling
Guidance for industry validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products
Guidance for industry studies to evaluate the safety of residues of veterinary drugs in human food, genotoxicity testing
Guidance for industry adverse reactions section of labeling for human prescription drug and biological products, content and format
Guidance for industry listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers
Guidance for industry expiration dating and stability testing of solid oral dosage form drugs containing iron
Guidance for industry postmarketing adverse event reporting for medical products and dietary supplements during an influenza pandemic
Guidance for industry submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes
Guidance for industry nonsterile semisolid dosage forms : scale-up and postapproval changes : chemistry, manufacturing, and controls : in vitro release testing and in vivo bioequivalence documentation
Guidance for industry bioanalytical method validation
Guidance for industry formal dispute resolution : scientific and technical issues related to pharmaceutical CGMP
Guidance for industry impurities, residual solvents in new veterinary medicinal products, active substances and excipients
Guidance for industry revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products
Guidance for industry class II special controls guidance document : in vitro HIV drug resistance genotype assay
Guidance for industry clinical lactation studies; study design, data analysis, and recommendations for labeling
Guidance for industry Q1E evaluation of stability data
Guidance for industry acute bacterial sinusitis, developing drugs for treatment
Guidance for industry pharmacogenomic data submissions, companion evidence
Guidance for industry part 11, electronic records : electronic signatures--scope and application
Guidance for industry variations in drug products that may be included in a single ANDA
Guidance for industry patient-reported outcome measures, use in medical product development to support labeling claims
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region Annex 2 Test for extractable volume of parenteral preparations general chapter
Guidance for industry supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors
Guidance for industry E 10 choice of control group and related issues in clinical trials
Guidance for industry year 2000 date change for computer systems and software applications used in the manufacture of blood products
Guidance for industry assay development for immunogenicity testing of therapeutic proteins
Guidance for industry investigating out-of-specification test results (OOS) for pharmaceutical production
Guidance for industry providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs)
Guidance for industry ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information
Guidance for industry effectiveness of anthelmintics, specific recommendations for feline
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions, annex 1, residue on ignition/sulphated ash, general chapter
Guidance for industry development and use of risk minimization action plans
Guidance for industry providing clinical evidence of effectiveness for human drug and biological products
Guidance for industry considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications
Guidance for industry M4S, the CTD, safety appendices
Guidance for industry Q9 quality risk management
Guidance for industry Part 11, electronic records electronic signatures, scope and application
Guidance for industry "computer crossmatch" (electronic based testing for the compatibility between the donor's cell type and the recipient's serum or plasma type)
Guidance for industry submitting type V drug master files to the Center for Biologics Evaluation and Research
Guidance for industry court decisions, ANDA approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act
Guidance for industry minimally manipulated, unrelated, allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution in patients with hematological malignancies
Guidance for industry Q1A(R2) stability testing of new drug substances and products
Guidance for industry providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format, lot release protocols
Guidance for industry content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
Guidance for industry Q3C impurities, residual solvents
Guidance for industry Q3B(R2) impurities in new drug products
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region Annex 4A Microbiological examination of nonsterile products : microbial enumeration tests general chapter
Guidance for industry residual solvents in drug products marketed in the United States
Guidance for industry available therapy
Guidance for industry label comprehension studies for nonprescription drug products : draft guidance
Guidance for industry PAC-ATLS : postapproval changes, analytical testing laboratory sites
Guidance for industry changes to an approved application for specified biotechnology and specified synthetic biological products
Guidance for industry Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
Guidance for industry consumer-directed broadcast advertisements
Guidance for industry immediate release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation
Guidance for industry safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency
Guidance for industry nonclinical safety evaluation of drug or biologic combinations
Guidance for industry Q3C tables and list
Guidance for industry recommendations for assessment of donor suitability and blood and blood product safety in cases of possible exposure to anthrax
Guidance for industry monoclonal antibodies used as reagents in drug manufacturing
Guidance for industry community-acquired bacterial pneumonia : developing drugs for treatment
Guidance for industry compliance with 21 CFR part 1271.150(c)(1), manufacturing arrangements
Guidance for industry pre-storage leukocyte reduction of whole blood and blood compoments intended for transfusion
Guidance for industry hypertension indication, drug labeling for cardiovascular outcome claims
Guidance for industry immunotoxicology evaluation of investigational new drugs
Guidance for industry submitting marketing applications according to the ICH-CTD format, general considerations
Guidance for industry dosage delivery devices for OTC liquid drug products
Guidance for industry information program on clinical trials for serious or life-threatening diseases and conditions
Guidance for industry preparation of IDEs and INDs for products intended to repair or replace knee cartilage
Guidance for industry effectiveness of anthelmintics, specific recommendations for equine
Guidance for industry population pharmacokinetics
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region Annex 3 Test for particulate contamination : subdivisible particles general chapter
Guidance for industry major, minor, and telephone amendments to abbreviated new drug applications
Guidance for industry quality systems approach to pharmaceutical CGMP regulations
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Guidance for industry
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