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Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements; the Draft Guidance issued by FDA this month does not ask the right questions.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
- First Circuit Clarifies When Clinical Labs Can Rely on Physician Orders
- Understanding the False Claims Act Statute of Limitations—and the Debate Over the “Last Overt Act” Rule
- Podcast: The Down-Low on Data for Value-Based Enterprises and Their Participating Providers – Diagnosing Health Care
- Second Circuit Affirms Denial of Preliminary Injunction in Challenge To N.Y. Law Restricting Weight Loss and Muscle Building Supplement Sales to Minors
- The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your Data”