Forces influencing generic drug development in the United States: a narrative review

Author:

Lee Chia-Ying,Chen Xiaohan,Romanelli Robert J.,Segal Jodi B.

Funder

U.S. Food and Drug Administration

Publisher

Springer Science and Business Media LLC

Subject

Pharmacy,Health Policy

Reference36 articles.

1. U.S. Department of Health & Human Services, Office of the Assistant Secretary for Planning and Evaluation. ASPE issue brief. Expanding the use of generic drugs. 2010. Retrieved from https://aspe.hhs.gov/basic-report/expanding-use-generic-drugs .

2. Anonymous, Generic Pharmaceutical Association. Generic drug savings in the U.S.: Seventh annual edition: 2015. 2015. Retrieved from http://www.gphaonline.org/media/wysiwyg/PDF/GPhA_Savings_Report_2015.pdf .

3. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products – general considerations. 2003. Retrieved from http://www.fda.gov/ohrms/dockets/ac/03/briefing/3995B1_07_GFI-BioAvail-BioEquiv.pdf .

4. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: bioavailability and bioequivalence studies submitted in NDAs or INDs — general considerations. 2014. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM389370.pdf .

5. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. 2013. Retrieved from http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377465.pdf .

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