Report: 71% of promised postmarketing commitments aren't started

Share this article:
FDA's latest annual report says 71% (911) of pending postmarketing study commitments promised by drug sponsors at the time of approval have never been started. This is almost unchanged from the year before (2006) when 899 (71%) were pending. Last year's FDA Amendments Act gave the agency authority to order more postmarketing studies to address safety issues.
Share this article:

Email Newsletters

More in Business Briefs

FDA reviews new painkiller

The candidate would be the first to put oxycodone and morphine in one capsule.

AbbVie's files all-oral HCV drug with FDA

AbbVie's all-oral HCV treatment filed off six Phase-III trials spanning 25 countries and 2,300 patients

Rumor: Pfizer offered to buy AstraZeneca

The rumored $101 billion bid would give Pfizer a foothold in imuno-oncology and diabetes.