Warning Letters Special Report: Pandemic Drove Focused Inspections, Alternative Approaches

In the first part of our in-depth series, the Pink Sheet outlines how 2022 warning letters reflected agency’s efforts to overcome COVID-19 travel restrictions. As pandemic abates, a new, less inspection-intensive normal could emerge.

Warning Letters Special Report
How the FDA found so many problems with so few inspections • Source: Shutterstock

Two factors enabled the US Food and Drug Administration to continue pressing the pharmaceutical industry on quality with warning letters in 2021 and 2022 even after the COVID-19 pandemic largely grounded its inspectorate, according to agency data analyzed by the Pink Sheet.

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Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.

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EU’s Critical Medicines Act: A Major Milestone Or Too Weak?

 

Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.

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How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

US FDA May Lose Some Autonomy Under Health Department’s General Counsel Reorg

 

Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.

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Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.