Executive Briefing Series (formerly The Food & Drug Letter)

An FDA final guidance highlights changes to the 1938 FD&C Act that give the agency new authority to require postmarket drug studies and clinical trials and make distinctions between postmarket requirements and commitments.

Drug sponsors may be able to collect less and better-targeted safety data in late-stage or postmarket trials if certain aspects of the safety profile are already well established, according to a new draft guidance.

Drugmakers conducting postmarket clinical trials should be required to conduct randomized clinical trials, according to the FDA’s Oncologic Drugs Advisory Committee.

While most drugmakers are good about keeping postmarket clinical trials on schedule, they don’t always file their required annual status reports on time.

The FDA granted approval to Affymax’s and Takeda’s once-monthly anemia treatment Omontys, but has loaded the companies with postmarketing requirements, including two safety studies and a risk evaluation and mitigation strategy (REMS).

An FDA warning that Merck could face fines for being months late on two postmarket study deadlines appears to be the first time the FDA has invoked new enforcement authority for postmarking requirements granted under the 2007 FDA Amendments Act (FDAAA) and may signal a new agency trend, a legal expert says.

For the U.S. to speed new drugs to market and retain its innovative lead, the “FDA should approve drugs based on safety and leave efficacy testing for postmarket studies,” former commissioner Andrew von Eschenbach proposed in a recent opinion piece in The Wall Street Journal.