Get Up To Speed on Medicare Inflation Rebates: HPM Issues Memorandum Summarizing CMS Final Rule; HPM and Riparian to Co-Host Webinar
FDA Law Blog
by Kurt R. Karst
18h ago
By Alan M. Kirschenbaum & Sophia R. Gaulkin ..read more
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HPM’s Larry Houck Presenting at WCF Opioid and Fentanyl Abuse Management Congress
FDA Law Blog
by Kurt R. Karst
18h ago
By Larry K. Houck ..read more
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FDA Appears to Be Granting Zombie Rare Pediatric Disease Designations Waiting for the Rare Pediatric Disease Priority Review Voucher Program to be Revived
FDA Law Blog
by Kurt R. Karst
18h ago
By Mark A. Tobolowsky & Frank J. Sasinowski ..read more
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Gone in a Puff of Smoke? FDA’s Proposed Rule on Maximum Nicotine Levels
FDA Law Blog
by Kurt R. Karst
1w ago
By Esther Petrikovsky & Sophia R. Gaulkin & David B. Clissold ..read more
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AI May Make Your Device More Efficient, but Be Prepared to Spend More Time on Design Documentation
FDA Law Blog
by Kurt R. Karst
1w ago
By Adrienne R. Lenz, Principal Medical Device Regulation Expert ..read more
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Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program
FDA Law Blog
by Kurt R. Karst
1w ago
By Faraz Siddiqui & Sara W. Koblitz ..read more
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Pharmacy Law and Licensing Highlights 2025
FDA Law Blog
by Kurt R. Karst
1w ago
By Sara M Keup ..read more
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FOIA Requires Transparency of Instructions to FDA Staff, Even When Those Instructions Are to Pause Communications with the Public
FDA Law Blog
by Kurt R. Karst
1w ago
By JP Ellison & John W.M. Claud ..read more
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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities
FDA Law Blog
by Kurt R. Karst
2w ago
By Mark A. Tobolowsky & Charles G. Raver & James E. Valentine ..read more
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What We’re Watching for in the Senate Confirmation Hearings to Consider Robert F. Kennedy, Jr. to be Secretary of HHS
FDA Law Blog
by Kurt R. Karst
2w ago
By John W.M. Claud & JP Ellison ..read more
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