In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same.
In light of these recent actions, what challenges are dietary supplement manufacturers now facing?
On this episode, Epstein Becker Green attorneys Jack Wenik, Teddy McCormick, Zach Taylor, and Tracey Gonzalez discuss recent updates to the FDA and FTC guidelines as they apply to ...
On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude ...
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Recent Updates
- Massachusetts Governor Maura Healey Signs into Law a Sweeping Health Care Market Oversight Bill
- Second Circuit Adopts “At Least One Purpose” Rule for False Claims Act Cases Premised on Anti-Kickback Statute Violations
- Supreme Court of Ohio Decides on a Peer-Review Privilege Issue in Stull v. Summa
- Unpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA
- Importance of Negotiating the Letter of Intent for Health Care Leases