FDA: Most Drugmakers Keep Postmarket Agreements

摘要

The FDA reports that most sponsors' required postmarket clinical trials are on schedule.rnHowever, postmarket commitments (PMCs), voluntary actions agreed to by sponsors, are lagging in comparison.rnAs of Sept. 30, 2009, there were 163 unique applicants with 242 NDAs/ANDAs that had either open postmarket requirements (PMRs), or PMCs, according to a CDER report published in the Tuesday Federal Register.