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Learning Tracks

CARES Act – Additional Reporting Requirements for Manufactures

Monday, November 8, 2021

2:30 p.m. - 3:30 p.m.

The CARES Act was signed into law on March 27, 2020, with the primary intention of providing  emergency relief for individuals, families and businesses affected by the ongoing COVID-19 pandemic.  It also included other provisions that affected the  pharmaceutical industry, such as drug shortage reporting.  Although the requirements outlined in Section 3112 Additional reporting requirement for manufactures in response to drug shortage were developed in response to the pandemic, these new reporting requirements will result in lasting obligations for drug and device manufacturers and suppliers, even after the COVID-19 pandemic is under control.  For the generics industry a significant effort will be required to comply with these new requirements, whether it be in creating new dynamics in the negotiation of supply contracts or establishing new quality and regulatory process governing the development, implementation and maintenance of redundancy risk management plans for all critical drug products and APIs.  In this session we would like to see the following: more clarity/direction as to FDA’s expectations on how industry should implement these new requirements; information on how  FDA will enforce these new requirements; update/overview of relevant guidances; industries perspective on what  this means for the generics industry and the challenges it will face.

Moderator: Brian McCormick
Vice President & Chief Regulatory Counsel Head, Global Regulatory Policy, Teva Pharmaceuticals

CAPT Christine Bina, RPh, MPH
Drug Shortage Staff, Office of Center Director, CDER, FDA

Ashley Boam, MSBE 
Office Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA

Sandra D’Agostino-Ferlisi
Director, Global Regulatory Intelligence & Policy, Apotex Inc.

Obinna Ugwu-Oju, MS

Division Director, Division of Quality Data Science, Office of Quality Surveillance, OPQ, CDER, FDA

Veda Walcott
Vice President, Global Regulatory Affairs and Compliance, Catalent Pharma Solutions

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