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US OTC Monograph Overhaul Like Makeover To Resemble Other FDA Drug Application Programs

 
• By Malcolm Spicer

In draft guidance on format and content for OMORs, CDER framed recommendations by same model it’s used for guidances on other drug applications, common technical document for registration developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.

• Source: Shutterstock

A draft guidance moves the drug approval program used for availability of most of the nonprescription drugs marketed in the US further away from its gridlocked past and into the more efficient process used for approving many drugs in and outside the US.

In in the document published on 12 April, the Food and Drug Administration also moves information expected in OTC monograph proposals for adding ingredients or indications to an OTC monograph...

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