- The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved December 23, 2024
- FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule December 17, 2024
- FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2) December 16, 2024
- Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules December 13, 2024
- After a Hiatus, the BLOCKING Act is Back! December 11, 2024
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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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- The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved December 23, 2024
- FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule December 17, 2024
- FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2) December 16, 2024
- Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules December 13, 2024
- After a Hiatus, the BLOCKING Act is Back! December 11, 2024
- 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