- Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement June 8, 2023
- An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking June 7, 2023
- AMCP Format for Formulary Submissions Revision – Comment Period Now Open! June 5, 2023
- CCP Improvements Allow Industry to Track Pre-submissions June 5, 2023
- CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program June 2, 2023
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U.S. Senate Passes Omnibus FDA Reform Bill
May 11, 2007Earlier this week, the U.S. Senate passed S. 1082, the “Food and Drug Administration Revitalization Act” (“FDARA”) by a vote of 93-1 (Sen. Bernie Sanders (I-VT) was the lone “nay” vote). The bill is an omnibus FDA reform and user fee package that, among other things, reauthorizes the Prescription Drug User Fee Act (i.e., PDUFA IV). The U.S. House of Representatives must now move forward on its version of the legislation. Once the House bill is passed, any differences between the bills will be reconciled in conference committee.
A copy of the version of the bill passed by the Senate was published in the Congressional Record, and is available here. Next week, FDA Law Blog plans to make a series of posts on various provisions of the bill.
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- Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement June 8, 2023
- An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking June 7, 2023
- AMCP Format for Formulary Submissions Revision – Comment Period Now Open! June 5, 2023
- CCP Improvements Allow Industry to Track Pre-submissions June 5, 2023
- CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program June 2, 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