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Philips Medical Systems is continuing discussions with the FDA over the company’s alleged deviations from current good manufacturing practices related to the production of its automated external defibrillators (AEDs), the firm told D&DL March 6.
The FDA got off to a slow start with new drug application (NDA) approvals in 2007, approving barely more than half as many as it had by this time last year.
The U.S. Court of Appeals for the District of Columbia heard arguments in a landmark case to decide if terminally ill patients have a constitutional right to use drugs that have not been fully approved by the FDA.
Novartis will position its newly approved antihypertensive Tekturna as a new treatment option in a therapeutic category where nearly seven out of 10 patients do not reach their respective blood pressure targets, the company said.
Organizations representing more than 60,000 pharmacists sent a letter to three senators discouraging them from introducing a bill that would strengthen federal regulations on compounded drugs.
The FDA has released a final guidance detailing new and current programs that convey drug safety information to the public as part of a larger drug safety initiative, the agency announced.
The FDA is reviewing the safety and efficacy of cough and cold medications for children to decide whether the methods used to determine dosages were sufficient, the agency announced.
The FDA issued a final guidance giving recommendations on how to design, conduct and evaluate clinical studies looking at the effects of corticosteroids on growth in children.
Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) have asked FDA Commissioner Andrew von Eschenbach to respond to an independent review that called the agency’s postmarketing surveillance system “dysfunctional.”
Organizations representing more than 60,000 pharmacists sent a letter to three senators discouraging them from introducing a bill that would strengthen federal regulations on compounded drugs.