The FDA added non compliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM).
Two leading House lawmakers are investigating FDA Commissioner Andrew von Eschenbach’s recent testimony on Ketek over concerns that he may have “intentionally misled” a subcommittee about the drug’s approval process.
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.
The FDA is inviting clinical trial sponsors to participate in a pilot project to test the electronic submission of case report form (CRF) data in extensible markup language (XML) based on the operational data model (ODM) developed by the Clinical Data Interchange Standards Consortium.