References for “Drug Policy 101: The state of the pharmaceutical evidence base”

  1. Food and Drug Administration, “Development and Approval Process (Drugs),”
    fda.gov/drugs/development-approval-process-drugs, June 13, 2018.
  2. Food and Drug Administration, “Postmarketing Requirements and Commitments: Introduction,” fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments, January 12, 2016.
  3. 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.
  4. 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.
  5. 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.
  6. Woloshin, S. et al., “The Fate of FDA Postapproval Studies.” New England Journal of Medicine, November 2011.
  7. Wallach, J., et al., “Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.” BMJ, April 16, 2018.
  8. Ghaemi, S., et al., “Publication Bias and the Pharmaceutical Industry: The Case of Lamotrigine in Bipolar Disorder.” Medscape Journal of Medicine, September 10, 2008.
  9. Schott, G., et al., “The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences.” Deutches Arzteblatt International, April 23, 2010.
  10. 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.
  11. Chary, K., “Expedited drug review process: Fast, but flawed.” Journal of Pharmacology & Pharmacotherapeutics, June 2016.