FDA's MaPP For NDA'd OTCs

The US Food and Drug Administration has issued a Manual of Policiesand Procedures setting guidelines for the review, approval and post-approval oversight of over-the-counter products which have gone through the New Drug Application process.

The MaPP, which took effect on February 1, represents a single, clear policy containing procedural guidelines which will help give priority and attention to OTCs at the agency, and help provide consistency and transparency in the prescription-to-OTC switch process, says the Nonprescription Drug Manufacturers Association, which has long championed such a move.

A key point in the new MaPP is its clear definition of the FDA Division of OTC Drug Products as an equal partner in the OTC new drug approval process, that the fact that the Division is given oversight of all post-approval OTC NDAs.