On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by ...
The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, ...
Specialty pharmaceuticals are typically high-cost therapies used to treat chronic, complex, or rare diseases. These products ...
It’s not just drugmakers reshaping the pharmaceutical sector; distributors are rapidly transforming, too. While most investors and policymakers focus on rising prescription drug prices or ...
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