- Dompé U.S. Pays $32 Million to Resolve Co-Pay Foundation Kickback Allegations Following Voluntary Self-Disclosure September 15, 2026
- Confirmatory Evidence for All? FDA’s Approval of Lytenava for Wet AMD Shows How Non-Rare Diseases Can Use Confirmatory Evidence and That “Failed” Studies Can Provide Confirmatory Evidence September 14, 2026
- FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies September 8, 2026
- HPM Presenting at IQVIA Annual Controlled Substances & State Regulatory Conference (Sept. 16-18) September 4, 2026
- Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI September 3, 2026
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Supreme Court hears oral argument in Riegel v. Medtronic, Inc.
December 4, 2007We previously reported that the Supreme Court had agreed to hear the PMA device preemption case Riegel v. Medtronic, Inc. The status of the case was in question earlier this fall because of an untimely motion to substitute the correct party (following the death of the petitioner). The Court exercised its discretion to grant the untimely motion, however. Today, attorneys for the parties, and the Solicitor General’s Office (supporting Medtronic) argued their respective positions before the Court.
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- Dompé U.S. Pays $32 Million to Resolve Co-Pay Foundation Kickback Allegations Following Voluntary Self-Disclosure September 15, 2026
- Confirmatory Evidence for All? FDA’s Approval of Lytenava for Wet AMD Shows How Non-Rare Diseases Can Use Confirmatory Evidence and That “Failed” Studies Can Provide Confirmatory Evidence September 14, 2026
- FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies September 8, 2026
- HPM Presenting at IQVIA Annual Controlled Substances & State Regulatory Conference (Sept. 16-18) September 4, 2026
- Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI September 3, 2026
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized