- Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development November 11, 2024
- To 513(g) or not to 513(g)? That is the question November 8, 2024
- While the Orphan Battles Wage, Jazz Takes a Loss November 7, 2024
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- From the Porcine to the Ridiculous to the Court of Appeals: Phibro’s Suit Against FDA Gets Muddy November 5, 2024
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HP&M Requests One-Year Comment Period for Draft NDI Guidance
July 26, 2011On July 26, 2011, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to a lengthy and controversial draft guidance on New Dietary Ingredient ("NDI") notifications that FDA issued earlier this month. Our previous post on the draft NDI guidance is available here.
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- Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development November 11, 2024
- To 513(g) or not to 513(g)? That is the question November 8, 2024
- While the Orphan Battles Wage, Jazz Takes a Loss November 7, 2024
- Who You Gonna Email? Digital Health Question Busters! November 6, 2024
- From the Porcine to the Ridiculous to the Court of Appeals: Phibro’s Suit Against FDA Gets Muddy November 5, 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