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Latest posts

• The Flexibility Papers, No. 2: Beyond Listening—Making Patient Input Matter 01 Nov 2026

  By James E. Valentine & Sarah Wicks & Jason Mercer, Ph.D. & Mary Bass & Gayatri R. Rao —

• DEA Clarifies Direct Delivery of Prescribed Controlled Substances to Practitioners 30 Oct 2026

  By Andrew J. Hull & Karla L. Palmer —

• The Flexibility Papers, No. 1: First Principles for a Rare Disease Framework 29 Oct 2026

  By James E. Valentine & Gayatri R. Rao & Frank J. Sasinowski —

• The PEPTIDE-L Wave Reaches HHS: Enforcement Discretion … Not the Finish Line 28 Oct 2026

  By Karla L. Palmer & Charles D. Snow —

• Six-Month Window: DOJ and HHS Launch Healthcare FCA Self-Disclosure Pilot 27 Oct 2026

  By Anne K. Walsh & JP Ellison —

• If You Change It, FDA Will Come: What the O.N. Diagnostics Warning Letter Means for SaMD Modifications 26 Oct 2026

  By Jennifer D. Newberger —

• DOJ’s New Whistleblower Program: Fast Cash for Fraud Tips 23 Oct 2026

  By Andrew J. Hull & Anne K. Walsh —

• Renewal Season is Here! FY 2027 Device Establishment Registration and Listing 20 Oct 2026

  By Steven J. Gonzalez —

• CDRH’s FY 2027 Proposed Guidances: Shorter Lists, Focused on Software and AI 18 Oct 2026

  By Steven J. Gonzalez & Adrienne R. Lenz, Principal Medical Device Regulation Expert —

• CMS Gains Permissive Exclusion Authority: Implications for Pharma and Medical Device Companies 16 Oct 2026

  By Anne K. Walsh —

• Rare Disease Refresh: FDA’s Rare Disease Framework Initiative 14 Oct 2026

  By James E. Valentine & Charles G. Raver & Frank J. Sasinowski —

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