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The FDA has issued a warning letter to Nephron Pharmaceuticals for allegedly failing to comply with current good manufacturing practices (cGMPs) and postmarketing adverse drug experience (PADE) reporting requirements.
Biotechnology firm Antigenics is preparing to launch a pivotal trial for its cancer vaccine Oncophage — a move that comes in the wake of preliminary data from a late-stage clinical trial that showed the drug extended the survival of advanced skin cancer patients.
The FDA has moved one step closer to allowing Inamed to market and sell its silicone gel-filled breast implants after the agency’s General and Plastic Surgery Devices Advisory Panel recommended against approving the company’s premarket application for the implants in April 2005 by a 5-4 vote.
The FDA has approved a new genetic test that will help doctors determine the right drug dosage for individual patients while minimizing harmful drug reactions — a move that advances the advent of personalized medicine.
Traditional drug development models no longer are effective for today's pharmaceutical firms, according to an FDA report that identifies opportunities for improving the R&D process, including through greater sharing of "precompetitive" data and earlier testing of drug candidates in humans.
The FDA has issued warning letters to two companies, charging the device manufacturers with nonconformance to the agency's quality system regulation (QSR).
The Center for Drug Evaluation and Research’s (CDER) staff is stretched thin and needs to be augmented if the FDA is to adequately address mounting drug-safety concerns, a panel of the agency’s top drug officials told an Institute of Medicine (IOM) committee that will recommend changes to the nation’s oversight system for marketed drugs.
An elderly woman enrolled in a clinical trial of Pfizer’s antiepileptic drug Lyrica suffered a serious adverse event after abruptly discontinuing the medication — an incident that researchers say could indicate the drug poses withdrawal problems.
Pharmaceutical firms developing antiviral drugs should conduct nonclinical studies of the product candidates before initiating Phase I clinical trials, according to an FDA draft guidance.