Overview

Over the past few decades there has been a dramatic decline in domestic production of active pharmaceutical ingredients (APIs), raising important questions about patient safety, national security, drug availability, vulnerability, and quality. These concerns have only grown since the COVID-19 pandemic. This webinar will cover the roots and consequences of declining domestic API and finished dosage manufacturing on the drug supply chain, regulatory options for improving the quality of foreign-produced APIs and/or increasing domestic API production, and what changes can be made by companies, FDA, or Congress to strengthen the drug supply chain.

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Speakers

Jeffrey K. Francer, Senior Vice President and General Counsel, Association for Accessible Medicines (AAM) and Member, FDLI Board of Directors
Michael Ganio, Senior Director, Pharmacy Practice and Quality, Center on Medical Safety and Quality, American Society of Health-System Pharmacists (ASHP)
Ronald T. Piervincenzi, CEO, US Pharmacopeia
Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, FDA
Moderated by Beth P. Weinman, Counsel, Ropes & Gray LLP

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