- A Busy Day in the (CDRH) Neighborhood: Updates to the CDS and General Wellness Guidance Documents January 8, 2026
- Prescribing/Dispensing “Outside the Usual Course of Professional Practice:” Trend, Coincidence or Passing Fancy? January 7, 2026
- MFN Drug Pricing Update: After GENEROUS, GUARD and GLOBE Issue From CMS’s Innovation Center – Part II January 6, 2026
- MFN Drug Pricing Update: After GENEROUS, GUARD AND GLOBE Issue From CMS’s Innovation Center – Part I January 5, 2026
- When FDA Can Make You Recall That Mascara January 2, 2026
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Off-label Promotion Qui Tam Suits – a YouTube Video by HP&M’s John R. Fleder
October 24, 2008Hyman, Phelps & McNamara, P.C.’s John R. Fleder has now appeared in a Washington Legal Foundation “Legally Brief” YouTube video. In the 6-minute video Mr. Fleder notes the recent increase in federal False Claims Act cases initiated by private whistleblowers based on alleged “off-label” use promotional activities involving pharmaceutical companies, and explains why recent court rulings have dismissed such cases, and cast doubt on the viability of any off-label use “qui tam” action.
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- A Busy Day in the (CDRH) Neighborhood: Updates to the CDS and General Wellness Guidance Documents January 8, 2026
- Prescribing/Dispensing “Outside the Usual Course of Professional Practice:” Trend, Coincidence or Passing Fancy? January 7, 2026
- MFN Drug Pricing Update: After GENEROUS, GUARD and GLOBE Issue From CMS’s Innovation Center – Part II January 6, 2026
- MFN Drug Pricing Update: After GENEROUS, GUARD AND GLOBE Issue From CMS’s Innovation Center – Part I January 5, 2026
- When FDA Can Make You Recall That Mascara January 2, 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