Posts tagged Third-Party Logistics Provider.
Blogs
6 minute read
Although FDA appropriately identified the need for guidance on the Effect of Section 585 of the FD&C Act on Drug Product Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements; the Draft Guidance issued by FDA this month does not ask the right questions.
In November 2013, Congress enacted the Drug Supply Chain Security Act ("DSCSA") with the intent of establishing a "Uniform National Policy" for wholesale distributor and third party logistics provider ("3PL") licensure. Congress hoped to achieve this goal by adding Section ...
Blog Editors
Recent Updates
- A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs
- Telehealth Cliff Averted, for Now (but September Is Six Months Away)
- The End of the Self-Affirmed GRAS Pathway?
- DEA Telemedicine Rules Further Delayed Until (Nearly) 2026
- Gender-Affirming Care Protections Eroded by Recent HHS Guidance and White House Executive Orders