Regulation of Drug Manufacturing: An Introduction
A session from FDLI’s Introduction to Drug Law and Regulation
Recorded April 22-23, 2025
Regulation of Drug Manufacturing: An Introduction
Learn Current Good Manufacturing Practices (cGMPs) for drugs and be able to define “adulteration” and “misbranding”. Understand the different types of inspections, including the differences between foreign and domestic inspections. Recognize the elements of a 483 observation and the components involved in closing out an inspection.
Joshua M. Oyster, Partner, Ropes & Gray, LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in April 2025.
JOSHUA M. OYSTER steers clients through a wide range of FDA regulatory issues to help them bring innovative products to market while also ensuring regulatory compliance. Josh is regularly called upon for help with a range of enforcement, regulatory compliance and transactional matters. Josh routinely helps companies navigate FDA inspections, Warning Letters, product recalls, and other compliance and enforcement matters. He is frequently tapped to analyze clients’ toughest questions related to complex or ambiguous regulatory requirements, drawing on his extensive experience with key policy and enforcement priorities, including medical product promotion, digital health, drug compounding, data integrity, CBD, and developments arising from the COVID-19 pandemic. In addition, Josh assists clients in assessing regulatory risks associated with potential acquisitions and investments in FDA-regulated entities.Get Access
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