- AI May Make Your Device More Efficient, but Be Prepared to Spend More Time on Design Documentation February 5, 2025
- Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program February 4, 2025
- Pharmacy Law and Licensing Highlights 2025 February 3, 2025
- FOIA Requires Transparency of Instructions to FDA Staff, Even When Those Instructions Are to Pause Communications with the Public January 31, 2025
- When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities January 30, 2025
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CMS Final Rule on the Medicaid Drug Rebate Program
August 9, 2007We previously reported on some of the highlights of the most notable provisions of the final rule issued by the Centers for Medicare & Medicaid Services (“CMS”) on the Medicaid Drug Rebate Program. Today, Hyman, Phelps & McNamara, P.C. issued a detailed memorandum summarizing the July 17th final rule. The memorandum, among other things, notes where the final rule differs from the proposed rule and prior CMS policy or guidance, and identifies issues that would benefit from further CMS clarification.
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- AI May Make Your Device More Efficient, but Be Prepared to Spend More Time on Design Documentation February 5, 2025
- Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program February 4, 2025
- Pharmacy Law and Licensing Highlights 2025 February 3, 2025
- FOIA Requires Transparency of Instructions to FDA Staff, Even When Those Instructions Are to Pause Communications with the Public January 31, 2025
- When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities January 30, 2025
- 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