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.
Generic-drug makers must submit self-identification information to the FDA by Dec. 3 to comply with the recently passed Generic Drug User Fee Amendments of 2012. Facilities that fail to self-identify will have their products labeled as misbranded, according to a Federal Register notice scheduled to publish Oct. 2. Drug Industry Daily