- Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments October 15, 2024
- A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight? October 14, 2024
- First Constitutional Challenge to FDA’s Civil Money Penalty Authority October 7, 2024
- Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices October 3, 2024
- Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government October 2, 2024
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FDA Grants 60-Day Extension to Comment on NDI Guidance
September 8, 2011On September 9, 2011, FDA will publish in the Federal Register a notice granting a 60-day extension, until December 2, 2011, to file comments on the draft guidance on New Dietary Ingredient (“NDI”) notifications that the Agency issued on July 5, 2011 (see our previous post on the draft guidance here). In late July, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to the lengthy and controversial draft guidance (see our previous post here).
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- Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments October 15, 2024
- A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight? October 14, 2024
- First Constitutional Challenge to FDA’s Civil Money Penalty Authority October 7, 2024
- Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices October 3, 2024
- Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government October 2, 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