Presentation: OTC MONOGRAPH REFORM IN THE CARES ACT: FDA INITIATED SAFETY ORDERS

Reviewed Topics:

  • Provide an overview of nonprescription drugs
  • Provide an overview of OTC Monograph Reform
  • Discuss how FDA identifies, evaluates, and responds to safety issues, including for OTC monograph drugs
  • Provide an overview of FDA-initiated administrative orders to address safety issues
  • Provide an overview of OTC Monographs FDA and comment submission

ABOUT GLOBAL REGULATORY PARTNERS INC:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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