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.
Ameridose is recalling all of its unexpired product as an ongoing FDA inspection of its Westborough, Mass., facility has raised sterility concerns. The company agreed to stop all pharmacy and manufacturing operations at the facility on Oct. 10 under an agreement with the Massachusetts Board of Registration in Pharmacy, the FDA said. Drug Industry Daily