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FDA Issues Notice on Maximum Civil Money Penalty Amounts
February 24, 2009By James P. Ellison –
We previously reported on FDA's Federal Register notice adjusting its civil penalties for inflation and noted our prior posts on the new civil penalty authority given to FDA in the FDA Amendments Act. As we explained in our earlier post, FDA's rule was published as a direct final rule, meaning that it would be withdrawn if significant adverse comments were received. Today, FDA published a notice stating that no significant adverse comments were received and therefore, the increased penalty amounts will become effective on March 27, 2009. While it has been quiet on the civil penalty front since our earlier post, we still see the possibility for increased civil penalty activity in the coming months.
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- Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute August 5, 2022
- ACI’s Paragraph IV Disputes Master Symposium – September 21-22, 2022 (Chicago) August 5, 2022
- ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual) August 5, 2022
- Teva Gets Knocked Down, But It Gets Up Again—and Petitions SCOTUS August 4, 2022
- It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs August 3, 2022
- 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