- Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft February 14, 2025
- Into the Ashtray: FDA’s Previous Proposal to Ban Menthol Cigarettes February 13, 2025
- Get Up To Speed on Medicare Inflation Rebates: HPM Issues Memorandum Summarizing CMS Final Rule; HPM and Riparian to Co-Host Webinar February 12, 2025
- HPM’s Larry Houck Presenting at WCF Opioid and Fentanyl Abuse Management Congress February 12, 2025
- FDA Appears to Be Granting Zombie Rare Pediatric Disease Designations Waiting for the Rare Pediatric Disease Priority Review Voucher Program to be Revived February 11, 2025
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Latest FDLI Update Magazine Features Analysis of Amarin Case Written by HP&M Attorneys
September 17, 2015The latest issue of the Food and Drug Law Institute’s “Update” magazine features an analysis of the recent case of Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. May 7, 2015), written by Hyman, Phelps & McNamara, P.C. attorneys David C. Gibbons and Jeffrey N. Wasserstein. The article, titled "Amarin Case Tests Limits of FDA Regulation of Off-Label Promotion," analyzes the regulatory background leading up to the case and where the Amarin case fits within recent First Amendment jurisprudence.
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- Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft February 14, 2025
- Into the Ashtray: FDA’s Previous Proposal to Ban Menthol Cigarettes February 13, 2025
- Get Up To Speed on Medicare Inflation Rebates: HPM Issues Memorandum Summarizing CMS Final Rule; HPM and Riparian to Co-Host Webinar February 12, 2025
- HPM’s Larry Houck Presenting at WCF Opioid and Fentanyl Abuse Management Congress February 12, 2025
- FDA Appears to Be Granting Zombie Rare Pediatric Disease Designations Waiting for the Rare Pediatric Disease Priority Review Voucher Program to be Revived February 11, 2025
- 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