Pharmaceutical Consultant – Marketed Unapproved Drugs

FDA has long held the position that they are subject to take aggressive action against companies that market drugs they consider unapproved.

FDA’s most recent notice to industry stated that “any unapproved new drug introduced onto the market after September 19, 2011 will be subject to immediate enforcement action, without prior notice and without regard to the enforcement priorities set out in CPG 440.100.” The Guidance notes that actions which FDA may take against such firms, “would typically involve one or more of the following:  requesting voluntary compliance; providing notice of action in a Federal Register notice; issuing an untitled letter; issuing a Warning Letter; or initiating a seizure, injunction, or other proceeding.”

Pharmaceutical Consultant, PDG, routinely assists companies in their responses to FDA actions and regulatory submissions such as 505(b)(2) NDAs. Contact us for more information.