We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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.
The FDA cited Niagara Pharmaceuticals for distributing its private label OTC sterile eyewash preparations without an approved new drug
application and for violating cGMPs.
During FDA inspections, manufacturers can use certain techniques to avoid Form 483s, or to respond to FDA observations, Cathy Burgess said during an FDAnews audioconference March 27.
The FDA will update its cGMP quality systems (QS) guidance to conform with international pharmaceutical QS guidelines,
the agency said March 23 at a Drug Information Association
conference.
Manufacturers should approach their responses to Form 483s and FDA warning letters with a global perspective, experts said at
an FDAnews audioconference March 27.