Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · Aug 2007
ReviewRegulatory considerations for determining postmarketing study commitments.
Postmarketing Study Commitments (PMCs) are, most commonly, agreements made by pharmaceutical companies at the time of an FDA approval to perform a study or studies to elucidate further characteristics of the drug under consideration. The role of PMCs in drug regulation has come under considerable scrutiny in recent years, particularly as discussions of drug safety have intensified. ⋯ When made, PMCs are described in the approval letters and are therefore publicly available. Concerns over whether PMCs were being duly performed, reported, and reviewed by FDA were addressed in the FDA Modernization Act of 1997, which required more detailed reporting by manufactures on their progress in meeting the PMCs and required FDA to report certain information publicly.
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Clin. Pharmacol. Ther. · Aug 2007
The pharmaceutical industry at risk: how excessive government regulation stifles innovation.
In the fall of 2006, I published a book, Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation. The book goes against the conventional wisdom found in the academic and popular literature on the topic by offering a more sympathetic view of the pharmaceutical industry.