Conferences and Speeches

American Conference Institute’s Second Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs

Tuesday, October 29, 2013
01:00 AM Eastern Daylight Time

FDA Partner Gary Yingling will join the American Conference Institute’s forum on Over the Counter Drugs.

Mr. Yingling’s session will explore continuing legal and regulatory conundrums associated with the Monograph System and the OTC Drug Review Process.

For over a decade, the OTC drug industry has been patiently awaiting the modernization of the FDA Monograph and OTC Review. In the interim, the industry has tried to devise work arounds in the absence of definitive guidance and often finds itself at the impasse of legal and regulatory uncertainties. This panel will explore current industry challenges and possible solutions in the void of definitive guidance. Topics will include

  • Monograph Modernization update
  • Differentiating between final monographs and tentative final monographs
  • Understanding the linkage between monograph modernization and the status of the OTC Review Process
  • Exploring legal and regulatory hindrances to OTC Review completion - FDA rulemaking
  • Assessing legal and regulatory concerns and consequences associated with antiquated quality standards in monographed products – impurities
  • Exploring potential legal and regulatory hindrances for inclusions of new technologies and dosage forms into the current monograph system - how can these technologies and dosage forms be utilized in the absence of guidance from the monograph?
  • Pros and cons of expansion of OTC Review

October 29, 2013

The Carlton Hotel
New York, NY

CLE Credit:
Please see event registration link for more information.