DeLauro is requesting FDA facility inspection records for ByHeart as the agency investigates an infant botulism outbreak ...
Pharmaceutical Technology on MSNOpinion
FDA inspection reveals critical supply chain vulnerabilities
Amanda Murphy, Senior Director at GlobalData, discusses how real-time intelligence can turns regulatory events into ...
An analysis of federal data shows a pronounced decline, despite alarming conditions found at some manufacturers.
A former CBP officer was sentenced to 15 years for allowing smugglers to transport vehicles filled with drugs into the U.S.
A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant ...
FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...
The appointment of Pazdur as CDER head comes shortly after the surprise ousting of George Tidmarsh and should quiet many of ...
U.S. audits of foreign country inspection systems for equivalency with America’s food safety regulations, such as the Federal Meat Inspection Act, the ...
The "FDA Regulatory Compliance for Drug and Biotech Products (Nov 12th - Nov 13th, 2025)" training has been added to ResearchAndMarkets.com's offering. Regulatory Compliance is the level of activity ...
GAINESVILLE, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- NeXtGen Biologics announced today the successful completion of a two-day inspection by the U.S. Food and Drug Administration (FDA). The inspection ...
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