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FDA Expectations of Supplier and Service Provider Controls

 

Learn how you can meet your obligations, reduce compliance risk, and take advantage of some likely new financial incentives.

Over the last decade, Congress and the Food and Drug Administration have recognized the challenges of overseeing complex pharmaceutical supply chains. As inputs to drugs have become more globalized and issues with quality and reliability have arisen, the agency has sought and used new enforcement tools to incentivize drug manufacturers to more carefully scrutinize supply chains. The added attention has created compliance risks and challenges - whether for getting a drug approved, post-market compliance, or evaluating drug companies for acquisitions. This topic will describe these risks and suggests ways in which companies can manage and minimize risk. It outlines the history of supply chain regulation, from statutory changes in 2012 to the CARES Act of 2020. It also examines current FDA initiatives, upcoming Biden Administration actions, and possible legislation. It also discusses the European and Chinese regulatory approach to supply chain oversight. Finally, the information suggests steps companies can take to meet their obligations and reduce compliance risk and to take advantage of some likely new financial incentives.

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FDA Expectations of Supplier and Service Provider Controls

Agenda

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FDA Expectations of Supplier and Service Provider Controls

Faculty

Howard Sklamberg

Howard Sklamberg

Arnold & Porter Kaye Scholer LLP

  • Partner in Arnold & Porter Kaye Scholer LLP’s Life Sciences and Healthcare Practice, focusing on FDA regulation
  • Practice includes advising on inspections and compliance actions, clinical trials, pre-market applications, investigations, and transactions involving FDA regulatory and enforcement issues
  • Senior official in FDA from 2010-2017, including Deputy Commissioner for Global Regulatory Operations and Policy and Director of the Office of Compliance for the Center for Drug Evaluation and Research
  • Can be contacted at 202-942-5075 or [email protected]
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FDA Expectations of Supplier and Service Provider Controls

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