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Less than a year after the FDA said it would begin focusing on quality metrics, ISPE has released the first data from a quality metrics pilot program designed to give the agency better insight. Read More
Biosimilars manufacturers are looking to the FDA for official guidance on several aspects of regulation, including naming and interchangeability. Read More
As Otsuka’s exclusivity protection for its blockbuster Tourette syndrome drug Abilify expired Monday, the FDA urged a federal judge not to grant the drugmaker’s last-ditch request for a court order blocking the agency from approving generic versions of the drug. Read More
Homeopathic drugs could face greater regulatory scrutiny by the FDA, as the agency weighs whether its existing regulations and enforcement policies are sufficient to deal with the dramatic uptick in natural products on the U.S. market. Read More
Despite agreeing to pay more than $500 million to settle a lawsuit stemming from pay-to-delay actions for its blockbuster narcolepsy drug Provigil, Israeli drugmaker Teva could still face billions more in court-ordered payments. Read More
The FDA is seeking specific suggestions on potential changes to the Generic Drug User Fee Act Performance Goals and Procedures, ahead of negotiations to reauthorize the law, which expires Sept. 30, 2017. Read More
With the Prescription Drug User Fee Act set to expire in September 2017, the FDA will kick into full gear on reauthorization negotiations this June, FDA Acting Commissioner Stephen Ostroff said Monday. Read More
The FDA is taking the unusual step of pressing Genervon Biopharmaceuticals to release all data from a Phase IIa trial of its amyotrophic lateral sclerosis drug, including an analysis of changes in patients’ lung function. Read More