- Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales December 5, 2023
- CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program December 4, 2023
- HPMers Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference December 1, 2023
- Are Predetermined Change Control Plans on the road to Global Harmonization? November 30, 2023
- FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting November 28, 2023
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FDAAA Enforcement Summary Now Available
February 6, 2008The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Gwen M. McKee and John R. Fleder discusses the enforcement provisions of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). While the enforcement provisions of FDAAA have frequently been ignored in public discussions about the new law, they are important for anyone working in the area to be aware of – particularly those entities affected by the new clinical trial database requirements, risk evaluation and mitigation strategies, or direct-to-consumer advertisements.
Those interested in a broader discussion of the new law can still access the previous, comprehensive analysis issued by Hyman, Phelps & McNamara, P.C.
Categories: Enforcement
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- Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales December 5, 2023
- CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program December 4, 2023
- HPMers Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference December 1, 2023
- Are Predetermined Change Control Plans on the road to Global Harmonization? November 30, 2023
- FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting November 28, 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