A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The Drug Enforcement Administration has placed Eisai's seizure medication Fycompa into schedule III of the Controlled Substances Act, clearing the final regulatory hurdle on the drug's pathway to market.
Washington, D.C.-based MedStar Health has signed a deal licensing to InnoVital Systems the intellectual property rights to the artificial muscle technology that it hopes will power the InVent diaphragm assist device.
Home » Battery Troubles Lead to Church & Dwight 483
Failure to report adverse events from a battery-operated toothbrush were among several observations in a Form 483 generated after a Jan. 9 to Feb. 13 inspection of Church & Dwight’s Princeton, N.J., facility. The company’s Spinbrush model was the subject of multiple customer complaints, including reports of batteries exploding; corrosive liquid leaking from the battery compartment and burning skin or mouth tissue; and the handle heating enough to burn. The GMP Letter