In the News

Format and Content Guidance Aligns US OTC Monograph Order Requests with NDA Process, HBW Insight

Wednesday, April 12, 2023

Partner Rebecca Dandeker is quoted in an HBW Insight article about draft guidance from the US Food and Drug Administration on the format and contents for over-the-counter (OTC) monograph order requests (OMORs). Rebecca addressed challenges smaller OTC marketers could face with the data guidelines and the submission process called for under the draft guidance.

“This increases the cost to submit an OMOR and favors the conglomerates who sell numerous OTC drugs,” Rebecca said.

Read the full HBW Insight article >>
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