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“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed foods are often targeted toward children and said the agency has focused on ...
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...
An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical ...
For a pharmaceutical company, a clean FDA inspection report is crucial for maintaining and expanding its presence in global markets ...
BrainStorm to Continue with Planned Phase 3b Trial and Remains Committed to Advancing Access for People Living with ALS NEW YORK, July 8, 2025 /PRNewswire/ -- BrainStorm ...
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