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.
FDA Commissioner Lester Crawford has announced several key personnel changes and permanent leadership appointments at the agency, a move that comes on the heels of his own confirmation to become permanent head of the FDA.
The FDA has begun a nationwide search for a permanent director of its Office of Drug Safety (ODS) — a move that comes more than 18 months after former director Victor Raczkowski left the agency for the private sector.
The FDA has pushed back the timeline for the reorganization of its Office of New Drugs (OND), which will now proceed in three phases, the last of which is expected to be completed in the fall.
A top FDA official has tried to allay pharmaceutical industry fears the agency will become overly conservative in evaluating product applications as a result of recent criticism over the FDA’s handling of drug safety problems.
The FDA’s proposed Drug Watch website for emerging drug safety issues could create legal headaches for pharmaceutical firms, industry executives told FDA officials.
The FDA’s new Drug Safety Oversight Board (DSB) will enforce strict conflict-of-interest rules to ensure its members make independent decisions, according to top agency officials who acknowledged that the duties of the board are still a work in progress.
Pharmaceutical companies will be alerted shortly before their products are placed on the FDA’s Drug Watch website for emerging drug-safety concerns, but firms will not be able to appeal or influence the agency’s decisions regarding the site.
As FDA drug-safety advisers mulled changes to the agency's risk assessment program for marketed drugs, a prominent whistle-blower chided the FDA's recent initiatives to improve its oversight of marketed drugs.
Having the FDA’s new drugs office and drug safety office within the agency’s Center for Drug Evaluation and Research (CDER) ensures efficient decisionmaking, expeditious resolution of disputes and the rapid dissemination of critical drug safety information, said the head of CDER.
The FDA's Center for Drug Evaluation and Research (CDER) is planning to develop nearly 50 new guidances this year, including recommendations on direct-to-consumer advertising and product labeling, according to CDER's recently released guidance agenda.