Most Drug Sponsors Conducting Required Postmarket Trials

After having to back down this summer from its attempt to remove Shire’s ProAmatine from the market after the company failed to conduct additional postmarket trials, the FDA reports that most sponsors’ required postmarket clinical trials are on schedule. However, postmarket commitments, voluntary actions agreed to by sponsors, are lagging in comparison. As of Sept. 30, 2009, there were 163 unique applicants with 242 NDAs/ANDAs that had either open postmarket requirements or postmarket commitments, according to a report from CDER.
Clinical Trials Advisor