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

Allergan reported to seek out Salix deal

The Wall Street Journal says the deal would add "another layer of intrigue" to the Allergan-Valeant hostilities.

India's Marck gets FDA Warning Letter

Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"

DOJ closes Brilinta investigation

AstraZeneca announced the end of the investigation Tuesday.