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Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements; the Draft Guidance issued by FDA this month does not ask the right questions.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
- Interested in Opening a Medical Spa? Here’s What You Need to Know
- Podcast: Key Changes in Finalized Antitrust Merger Guidelines – Diagnosing Health Care
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
- Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams
- Importance of Negotiating Assignment and Subletting Provisions in Health Care Leases