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23/01/2024 24/01/2024 America/Toronto OTC Drugs OTC Drugs
January 23 – 24, 2024
New York Bar Association, New York, NY
Please visit https://www.americanconference.com/otc-drugs/ for more information and updates. New York Bar Association, New York, NY true DD/MM/YYYY 1440 use-title -
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23/01/2024 24/01/2024 America/Toronto OTC Drugs OTC Drugs
January 23 – 24, 2024
New York Bar Association, New York, NY
Please visit https://www.americanconference.com/otc-drugs/ for more information and updates. New York Bar Association, New York, NY true DD/MM/YYYY 1440 use-title -
Navigating OTC Post-Market Challenges
Responding to the Latest FDA Inspection and Enforcement Activity
Frederick A. Stearns
Partner
Keller and Heckman LLP
Cathy Burgess
Partner
Alston & Bird LLP
David Horowitz
Partner
Hogan Lovells US LLP
- Investigating recent trends in OTC drug manufacturing inspections
- Anticipating and preparing for both unannounced and routine inspections by FDA
- Preparing for a paper inspection vs. an in-person inspection from FDA
- Examining how new FDA inspection tools and remote regulatory assessments may help to increase inspection efficiencies
- Shedding light on the latest areas of focus for FDA enforcement
- Examining the latest wave of FDA warning letters issued to OTC drug manufacturers regarding GMP issues – what trends are we seeing and what are the implications?
- Examining the role of compliance and ingredient transparency in shaping OTC products’ market presence