Format And Content Guidance Aligns US OTC Monograph Order Requests With NDA Process

Data and other information draft recommends for OMORs include combined with the common technical document-framed formatting and submitting may be particularly challenging for businesses which market a limited number of OTC drugs, particularly smaller firms.

The US Food and Drug Administration packed full of instructions a draft guidance on format and content for OTC monograph order requests (OMORs) but still made room to includes requests for more information than firms likely are accustomed to providing for monograph drugs.

“The extent of the data and information details recommended by FDA shows that many OMORs will involve a highly complex...