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Antitrust concerns and the FDA approval process : hearing before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifteenth Congress, first session, July 27, 2017
| Antitrust concerns and the FDA approval process : hearing before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifteenth Congress, first session, July 27, 2017 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2018 |
| Descrizione fisica | 1 online resource (iv, 51 pages) |
| Soggetto topico |
Drugs - United States - Testing
Drug approval - United States Drugs - Safety regulations - United States Medical instruments and apparatus - Safety regulations - United States Generic drugs - United States Competition - United States Antitrust law - United States Antitrust law Competition Drug approval Drugs - Safety regulations Drugs - Testing Generic drugs Medical instruments and apparatus - Safety regulations |
| Soggetto genere / forma |
Legislative hearings.
Rules. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Antitrust concerns and the FDA approval process |
| Record Nr. | UNINA-9910709758903321 |
| Washington : , : U.S. Government Publishing Office, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Authorized generic drugs : short and long-term competitive effects / / Edward R. Nelson and Jerry G. Wright, editors
| Authorized generic drugs : short and long-term competitive effects / / Edward R. Nelson and Jerry G. Wright, editors |
| Pubbl/distr/stampa | New York : , : Nova Biomedical, , [2012] |
| Descrizione fisica | 1 online resource (226 pages) : illustrations |
| Disciplina | 615.1 |
| Collana | Pharmacology research, safety testing, and regulation |
| Soggetto topico | Generic drugs |
| ISBN | 1-62257-152-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910148724503321 |
| New York : , : Nova Biomedical, , [2012] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Las drogas baratas aprobadas por la FDA [[electronic resource] ] : los productos genéricos deben satisfacer altos niveles
| Las drogas baratas aprobadas por la FDA [[electronic resource] ] : los productos genéricos deben satisfacer altos niveles |
| Edizione | [Rev. Jan. 2004.] |
| Pubbl/distr/stampa | Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2004] |
| Descrizione fisica | 1 sheet : digital, PDF file |
| Collana |
Just the facts
Publication |
| Soggetto topico |
Generic drugs
Drugs - Testing Pharmaceutical industry - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Altri titoli varianti | Drogas baratas aprobadas por la FDA |
| Record Nr. | UNINA-9910695439403321 |
| Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Examining issues related to competition in the pharmaceutical marketplace : a review of the FTC report, generic drug entry prior to patent expiration : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, second session, June 13 and October 10, 2002
| Examining issues related to competition in the pharmaceutical marketplace : a review of the FTC report, generic drug entry prior to patent expiration : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, second session, June 13 and October 10, 2002 |
| Pubbl/distr/stampa | Washington, DC : , : U.S.Government Printing Office, , 2002 |
| Descrizione fisica | 1 online resource (iii, 142 pages) |
| Altri autori (Persone) | MurisTimothy J |
| Soggetto topico |
Generic drugs
Drugs - Prices - United States Competition Pharmaceutical industry |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Examining issues related to competition in the pharmaceutical marketplace |
| Record Nr. | UNINA-9910706890203321 |
| Washington, DC : , : U.S.Government Printing Office, , 2002 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Examining the Senate and House versions of the "Greater Access to Affordable Pharmaceuticals Act" : hearing before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, first session, August 1, 2003
| Examining the Senate and House versions of the "Greater Access to Affordable Pharmaceuticals Act" : hearing before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, first session, August 1, 2003 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2004 |
| Descrizione fisica | 1 online resource (iv, 158 pages) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
Prescription pricing - Law and legislation - United States
Generic drugs - United States Drugs - United States Drugs - United States - Cost control Pharmaceutical policy - United States Drugs Drugs - Cost control Generic drugs Pharmaceutical policy Prescription pricing - Law and legislation |
| Soggetto genere / forma |
Patents.
Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Examining the Senate and House versions of the Greater Access to Affordable Pharmaceuticals Act |
| Record Nr. | UNINA-9910714913503321 |
| Washington : , : U.S. Government Printing Office, , 2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
FDA-approved bargain drugs [[electronic resource] ] : generic products must meet high standards
| FDA-approved bargain drugs [[electronic resource] ] : generic products must meet high standards |
| Edizione | [Rev. Dec. 2003.] |
| Pubbl/distr/stampa | Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2003] |
| Descrizione fisica | 1 sheet : digital, PDF file |
| Collana |
Just the facts
Publication |
| Soggetto topico |
Generic drugs
Drugs - Testing Pharmaceutical industry - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA-approved bargain drugs |
| Record Nr. | UNINA-9910695574703321 |
| Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2003] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Frecuentes preguntas acerca de las drogas genéricas [[electronic resource]]
| Frecuentes preguntas acerca de las drogas genéricas [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, Md.] : , : Dept. of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, , [2004] |
| Descrizione fisica | 2 unnumbered pages : HTM file |
| Soggetto topico |
Generic drugs
Drugs - United States - Generic substitution |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Record Nr. | UNINA-9910698180403321 |
| [Rockville, Md.] : , : Dept. of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer
| Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
| Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
| Descrizione fisica | 1 online resource (292 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
| Collana | Drugs and the pharmaceutical sciences |
| Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products - Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms
Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products - Manufacture and Quality ; Index; Color Insert ; Back Cover |
| Record Nr. | UNINA-9910459270503321 |
| New York : , : Informa Healthcare USA, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer
| Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
| Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
| Descrizione fisica | 1 online resource (292 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
| Collana | Drugs and the pharmaceutical sciences |
| Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
| ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products - Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms
Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products - Manufacture and Quality ; Index; Color Insert ; Back Cover |
| Record Nr. | UNINA-9910792350103321 |
| New York : , : Informa Healthcare USA, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer
| Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
| Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
| Descrizione fisica | 1 online resource (292 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
| Collana | Drugs and the pharmaceutical sciences |
| Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
| ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products - Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms
Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products - Manufacture and Quality ; Index; Color Insert ; Back Cover |
| Record Nr. | UNINA-9910800062003321 |
| New York : , : Informa Healthcare USA, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
