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Supplier Qualification in the Pharmaceutical Supply Chain

The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...

The FDA’s Enforcement of Section 503B of the Federal Food, Drug, and Cosmetic Act

The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...

FDA Provides Recommendations on Injectable Drug Dose Labeling

On October 21, 2015, FDA released a draft guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose,...

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