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The FDA plans this spring to reorganize its divisions and offices that handle new drugs -- a move that could bring changes to who oversees drugmakers' products.
The FDA has announced name and address changes for a pair of divisions within the Center for Drug Evaluation and Research’s (CDER’s) Office of Compliance.
An FDA scientist’s controversial conclusion that a link exists between antidepressant use and suicide in pediatric patients appears to have been vindicated, according to the former director of the National Institute of Mental Health.
The FDA is planning to commence a nationwide search for a director for its soon-to-be-created Office of Oncology Drug Products (ODP), according to FDA acting Commissioner Lester Crawford.
The FDA plans to create an Office of Oncology Drug Products (ODP), as well as a new crosscutting oncology program, to get more cancer drugs on the market, according to an official at the agency’s Center for Drug Evaluation and Research (CDER).
Two House Republicans have joined a Senate colleague in asking for an investigation into how the FDA manages internal disagreements over the handling of drug safety matters.
The FDA is on track to approve more new molecular entities (NMEs) this year than it did last year. For the first six months of 2004, the FDA approved 12 NMEs, compared to only seven for the comparable period in 2003 and 17 NMEs for all of 2002.
Sen. Hillary Clinton (D-N.Y.) is the latest to join several other federal lawmakers seeking more detail about the rationale behind the FDA’s decision last month to deny OTC status for Barr Pharmaceutical’s Plan B emergency oral contraceptive.
To help expedite the drug approval process, the FDA is stepping up its efforts to get pharmaceutical companies to submit more complete applications for new molecular entities (NMEs).
The FDA appears to have leaned on one of its scientists to present unreliable and misleading data about a possible link between antidepressant use and suicide in children, according to a June 16 letter from the Senate Finance Committee chairman to HHS Secretary Tommy Thompson.