CARES Act: OTC Pathway for Novel Drug Dosage Form Technologies

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Thursday, May 28, 2020
02:00 PM - 03:00 PM ET
01:00 PM - 02:00 PM CT
11:00 AM - 12:00 PM PT

With the advent of the CARES Act, new technologies that could be used in drug development and the creation of novel dosage forms for over-the-counter drugs will open opportunities for creators and developers.  Join us for a webinar that will explore options that will allow them to take their creations to market in a potentially faster and simpler way than the New Drug Application process. 

Topics will include:

  • Administrative Order process for drugs, a new FDA process created by the CARES Act
  • Differences from the current OTC Monograph process
  • Opportunities and pathway for development of novel technologies, including new OTC drug dosage forms
  • Preparing OTC Monograph Order Request (OMOR) Submissions

CLE credit: CLE credit in CA, FL, IL, NJ (via reciprocity), NY, PA, TX, and VA is currently pending approval.