Regulation of Safety, Efficacy, and Quality

Author:

Olson M.K.

Publisher

Elsevier

Reference41 articles.

1. A comparative analysis of drug safety withdrawals in the UK and US (1971–1992): Implications for current regulatory thinking and policy;Abraham;Social Science and Medicine,2005

2. Begosh, A., Goldsmith J., Hass E., et al. (2006). Black box warnings and drug safety: Examining the determinants and timing of FDA warning labels, NBER Working Paper 12803.

3. Industry funding of the FDA: Effects of PDUFA on approval times and withdrawal rates;Berndt;Nature Reviews: Drug Discovery,2005

4. Drug review deadlines and subsequent safety problems;Carpenter;New England Journal of Medicine,2008

5. Errata and corrected estimates;Carpenter;New England Journal of Medicine,2008

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1. Marketing Strategy & Regulatory Perspective for Natural Immunomodulators;Natural Immunomodulators: Promising Therapy for Disease Management;2023-05

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