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
- DOJ’s Final Rule on Bulk Data Transfers: The First 180 Days
- California Governor Signs SB 351, Strengthening the State’s Corporate Practice of Medicine Doctrine
- No Remuneration Plus No "But-For" Causation (Between an Alleged Kickback and Claims Submitted to the Government) Means No FCA Violation, District Court Says
- Novel Lawsuits Allege AI Chatbots Encouraged Minors’ Suicides, Mental Health Trauma: Considerations for Stakeholders
- DOJ Creates Civil Division Enforcement & Affirmative Litigation Branch: Implications for Health Care and Beyond