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FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

USA - November 15 2018 On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile...

Lowell Zeta, David Horowitz.


FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

USA - October 25 2018 On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for...

David Horowitz.


FDA schedules public hearing on solutions to drug shortages

USA - October 8 2018 FDA schedules public hearing on solutions to drug shortages October 08, 2018 The U.S. Food and Drug Administration (FDA) has announced it will hold a...

Christopher Fanelli.


FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A

USA - September 21 2018 Yesterday, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to...

Delia A. Deschaine, Lowell Zeta, Jason Hadges, Mike Druckman.


FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

USA - September 5 2018 Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug...

Christopher Fanelli, Lowell Zeta.