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.
Rep. Ed Markey (D-Mass.) plans to introduce a bill that would force larger-volume compounders to register with the FDA as drug manufacturers. Those compounders would be subject to the same FDA inspection authority as drug manufacturers, according to the Verifying Authority and Legality in Drug Compounding Act. Drug Industry Daily