Articles Tagged with ''FDA''

Lawmakers Request PDUFA Timing Information From FDA

Two leading House members sent a letter to FDA Commissioner Andrew von Eschenbach asking him when he would have to alert agency employees about possible layoffs if the Prescription Drug User Fee Act (PDUFA) is not reauthorized.

Read More

FDA Gets New Chief Information Officer

The Centers for Medicare and Medicaid Service’s (CMS) Timothy Stitely will become the FDA’s chief information officer, the agency announced. At the CMS, Stitely served as the director of Information Services Design & Development.

Read More

Tackle Ambiguities Upfront in Emergency Research

Sponsors seeking to conduct emergency research under the FDA regulation that allows a waiver of informed consent, or a parallel waiver to the Common Rule issued by the HHS secretary, should address a host of difficult ethical issues and ambiguities while developing the trial protocol, according to an expert.

Read More