- Good Things Came in Threes for These Drug Companies: Three Judges at the Third Circuit Found for Three Drug Makers in 340B Contract Pharmacy Case February 5, 2023
- Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act February 3, 2023
- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
- An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer January 30, 2023
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FDAAA § 912 – A Fundamental Shift in the Dividing Line Between Foods and Drugs
April 16, 2008In a previous post we opined that § 912 of the FDA Amendments Act (“FDAAA”) could represent a fundamental shift in the dividing line between foods and drugs. For our most recent thoughts on that subject, we refer you to the column we recently published in FDLI Insighter. There, we examine the potential of § 912 not only to reduce the historic flexibility by which an article may be deemed a food or a drug, but more importantly to deter innovation in the research and development of new food ingredients.
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- Good Things Came in Threes for These Drug Companies: Three Judges at the Third Circuit Found for Three Drug Makers in 340B Contract Pharmacy Case February 5, 2023
- Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act February 3, 2023
- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
- An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer January 30, 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