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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. FDA stated that the firm received 96 U.S. Summaries of the most striking recently released Warning Letters are included below. Dextrum Laboratories Inc.

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Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally. What is the role of post-market surveillance in medical device safety?