Clinical Development of Biologics Approved by the US Food and Drug Administration, 2003-2016

Author:

Alexander G. Caleb,Ogasawara Ken,Wiegand Dana,Lin Dora,Breder Christopher D.ORCID

Funder

Center for Regulatory Excellence in Regulatory Science

Publisher

Springer Science and Business Media LLC

Subject

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

Reference12 articles.

1. US Food and Drug Administration New Molecular Entity (NME) Drug and New Biologic Approvals. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm373420.htm. Published September 1, 2015. Accessed January 6, 2017.

2. Philippidis A. The top 15 best-selling drugs of 2016. Genetic Engineering and Biotechnology News. https://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868. Published March 2, 2017. Accessed December 24, 2017.

3. Downing NS, Aminawung JA, Shah ND, et al. Regulatory review of novel therapeutics—comparison of three regulatory agencies. N Engl J Med. 2012;366(24):7.

4. Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA. 2014;311(4):368-377.

5. Ogasawara K, Breder CD, Lin DH, Alexander GC. Exposure- and dose-response analyses in dose selection and labeling of FDA-approved biologics. Clin Ther. 2018;40(1):95-102.e2.

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