- Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3 . . . and PART 3½) March 14, 2024
- Drugs Companies Clap Back at Congress…Then Get Sued March 13, 2024
- Bad Labs! Bad Labs? Whatcha Gonna Do? March 12, 2024
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- HP&M’s Larry Houck A Panelist at FDLI’s Cannabis Regulation Conference March 10, 2024
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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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- Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3 . . . and PART 3½) March 14, 2024
- Drugs Companies Clap Back at Congress…Then Get Sued March 13, 2024
- Bad Labs! Bad Labs? Whatcha Gonna Do? March 12, 2024
- 15 Years Strong: Rare Disease Week’s Remarkable Journey of Support March 10, 2024
- HP&M’s Larry Houck A Panelist at FDLI’s Cannabis Regulation Conference March 10, 2024
- 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