The Author(s) Pharmacovigilance and Risk Management Strategies 2017: Overview of the Generic Drug Program and Surveillance

Author:

Chazin Howard D.ORCID,Peters John R.,Catterson Debra M.,Osterhout James L.,Forsyth Linda M.,Lee Jung E.,Kim Edward K.,Feibus Karen B.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference23 articles.

1. Association of Accessible Medications. 2017 generic drug access and savings in the United States report. https://www.accessiblemeds.org/resources/blog/2017-generic-drug-access-and-savings-us-report. Accessed August 14, 2017.

2. Generic Drug User Fee Act Reauthorization (GDUFA II), Biosimilar User Fee Act Reauthorization (BsUFA II). https://www.fda.gov/NewsEvents/Testimony/ucm548273.htm. Accessed August 14, 2017.

3. Uhl K, Peters JR, Chazin H. The FDA ensures quality and safety of generic drugs in the United States. ASCO Post, December 10, 2016. http://www.ascopost.com/issues/december-10-2016/the-fda-ensures-quality-and-safety-of-generic-drugs-in-the-united-states/. Accessed August 17, 2017.

4. FDA. Generic drugs undergo rigorous FDA scrutiny. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm340343.htm. Accessed June 26, 2017.

5. Orange Book preface. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm. Accessed August 14, 2017.

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