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An Act to Amend the Federal Food, Drug, and Cosmetic Act with Respect to the Scope of New Chemical Exclusivity
| An Act to Amend the Federal Food, Drug, and Cosmetic Act with Respect to the Scope of New Chemical Exclusivity |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2021] |
| Descrizione fisica | 1 online resource (4 unnumbered pages) |
| Soggetto topico |
Drug approval - United States
Pharmaceutical policy - United States Drug approval Pharmaceutical policy |
| Soggetto genere / forma | Statutes and codes. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910716073503321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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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Center for Drug Evaluation and Research update
| Center for Drug Evaluation and Research update |
| Pubbl/distr/stampa | [Silver Spring, MD], : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] |
| Descrizione fisica | 1 online resource |
| Disciplina | 615 |
| Soggetto topico |
Drugs - United States - Testing
Pharmaceutical policy - United States Drug approval - United States Drug Approval Drug Industry Drug approval Drugs - Testing Pharmaceutical policy |
| Soggetto genere / forma |
Statistics.
Periodicals. |
| ISSN | 2150-2390 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Update
CDER ... update Improving public health through human drugs |
| Record Nr. | UNINA-9910702844903321 |
| [Silver Spring, MD], : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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FDA user fee agreements : improving medical product regulation and innovation for patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, first session on ... March 21, 2017
| FDA user fee agreements : improving medical product regulation and innovation for patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, first session on ... March 21, 2017 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2018- |
| Descrizione fisica | 1 online resource (volumes) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
User charges - United States
Drug approval - United States Medical supplies - Certification - United States Drug approval User charges |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA user fee agreements |
| Record Nr. | UNINA-9910709965203321 |
| Washington : , : U.S. Government Publishing Office, , 2018- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Generic drug user fee amendments : accelerating patient access to generic drugs : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, second session ... January 28, 2016
| Generic drug user fee amendments : accelerating patient access to generic drugs : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, second session ... January 28, 2016 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2018 |
| Descrizione fisica | 1 online resource (ii, 39 pages) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
Generic drugs - Prices - United States
Drugs - Prices - United States Prescription pricing - United States Drug accessibility - Government policy - United States Drugs - Generic substitution Drug approval - United States Drug approval Drugs - Prices Generic drugs - Prices Prescription pricing |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Generic drug user fee amendments |
| Record Nr. | UNINA-9910706703803321 |
| Washington : , : U.S. Government Publishing Office, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance
| Guidance for industry [[electronic resource] ] : pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, , [2004] |
| Descrizione fisica | 10 pages : digital, PDF file |
| Soggetto topico |
Drug approval
Anti-infective agents in veterinary medicine Drug resistance in microorganisms Food animals |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698934303321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : submitting marketing applications according to the ICH-CTD format, general considerations
| Guidance for industry [[electronic resource] ] : submitting marketing applications according to the ICH-CTD format, general considerations |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2001] |
| Descrizione fisica | 13, 1, 2 pages : digital, PDF file |
| Soggetto topico |
Drug approval
Drugs - Marketing Clinical trials - Reporting |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698953703321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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The impact of medical device and drug regulation on innovation, jobs, and patients [[electronic resource] ] : a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011
| The impact of medical device and drug regulation on innovation, jobs, and patients [[electronic resource] ] : a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2012 |
| Descrizione fisica | 1 online resource (iii, 116 pages) |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations - United States
Drug approval - United States Medical instruments and apparatus industry - California Pharmaceutical industry - California Drug approval Medical instruments and apparatus industry Medical instruments and apparatus - Safety regulations Pharmaceutical industry |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Impact of medical device and drug regulation on innovation, jobs, and patients |
| Record Nr. | UNINA-9910701840703321 |
| Washington : , : U.S. G.P.O., , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Improving and accelerating therapeutic development for nervous system disorders : workshop summary / / Sheena M. Posey Norris [and three others], rapporteurs ; Forum on Neuroscience and Nervous System Disorders : Board on Health Sciences Policy
| Improving and accelerating therapeutic development for nervous system disorders : workshop summary / / Sheena M. Posey Norris [and three others], rapporteurs ; Forum on Neuroscience and Nervous System Disorders : Board on Health Sciences Policy |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , 2014 |
| Descrizione fisica | 1 online resource (119 p.) |
| Disciplina | 615.1 |
| Soggetto topico |
Drug development
Drug approval Clinical trials |
| Soggetto genere / forma | Electronic books. |
| ISBN | 0-309-29247-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Contents""; ""1 Introduction and Overview""; ""2 Drug Development Challenges""; ""3 Target Identification""; ""4 Target Validation""; ""5 Opportunities to Improve and Accelerate the Drug Development Pipeline""; ""6 Perspectives on Next Steps""; ""Appendix A: References""; ""Appendix B: Workshop Agenda""; ""Appendix C: Registered Attendees"" |
| Record Nr. | UNINA-9910464764403321 |
| Washington, District of Columbia : , : National Academies Press, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Improving and accelerating therapeutic development for nervous system disorders : workshop summary / / Sheena M. Posey Norris [and three others], rapporteurs ; Forum on Neuroscience and Nervous System Disorders : Board on Health Sciences Policy
| Improving and accelerating therapeutic development for nervous system disorders : workshop summary / / Sheena M. Posey Norris [and three others], rapporteurs ; Forum on Neuroscience and Nervous System Disorders : Board on Health Sciences Policy |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , 2014 |
| Descrizione fisica | 1 online resource (119 p.) |
| Disciplina | 615.1 |
| Soggetto topico |
Drug development
Drug approval Clinical trials |
| ISBN |
0-309-29249-2
0-309-29247-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Contents""; ""1 Introduction and Overview""; ""2 Drug Development Challenges""; ""3 Target Identification""; ""4 Target Validation""; ""5 Opportunities to Improve and Accelerate the Drug Development Pipeline""; ""6 Perspectives on Next Steps""; ""Appendix A: References""; ""Appendix B: Workshop Agenda""; ""Appendix C: Registered Attendees"" |
| Record Nr. | UNINA-9910789232503321 |
| Washington, District of Columbia : , : National Academies Press, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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