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- Food and Drug Administration, “Development and Approval Process (Drugs),”
fda.gov/drugs/development-approval-process-drugs, June 13, 2018.
- Food and Drug Administration, “Postmarketing Requirements and Commitments: Introduction,” fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments, January 12, 2016.
- Sasinowski, F. et al., “Quantum of Effective Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2015.” Therapeutic Innovation & Regulatory Science, April 27, 2015.
- Peter Loftus, “Fast-Track Drug Approval, Designed for Emergencies, Is Now Routine.” The Wall Street Journal, July 5, 2019, wsj.com/articles/fast-track-drug-approval-designed-for-emergencies-is-now-routine-11562337924.
- Naci, H., et al., “Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.” JAMA, August 15, 2017.
- Woloshin, S. et al., “The Fate of FDA Postapproval Studies.” New England Journal of Medicine, November 2011.
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- Ghaemi, S., et al., “Publication Bias and the Pharmaceutical Industry: The Case of Lamotrigine in Bipolar Disorder.” Medscape Journal of Medicine, September 10, 2008.
- Schott, G., et al., “The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences.” Deutches Arzteblatt International, April 23, 2010.
- Food and Drug Administration, “Proposal to Withdraw Approval for Breast Cancer Indication for AVASTIN (Bevacizumab),” fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf, November 18, 2011.
- Chary, K., “Expedited drug review process: Fast, but flawed.” Journal of Pharmacology & Pharmacotherapeutics, June 2016.