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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 As we explained in our earlier post, FDA's rule was published as a direct final rule, meaning that it would be withdrawn if significant adverse comments were received.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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- A (Not So) New Avenue to Challenge Misleading Rx Promotion – NAD January 25, 2023
- Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans January 24, 2023
- FDORA Enacted; HP&M Issues Detailed Summary and Analysis January 23, 2023
- CMS Rolls up its Sleeves on Price Negotiations, Sets Agenda for 2026 Negotiated Prices January 19, 2023
- FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests January 17, 2023
- 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