Partner Rebecca Dandeker is quoted in an HBW Insight article about draft guidance from the US Food and Drug Administration on the format and contents for over-the-counter (OTC) monograph order requests (OMORs).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challenges smaller OTC marketers could face with the data guidelines and the submission process called for under the draft guidance.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