- 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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FDORA Enacted; HP&M Issues Detailed Summary and Analysis
January 23, 2023On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022). FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. The law enacts significant changes that will have considerable short- and long- term effects on the regulated industry and the FDA.
FDORA includes six subtitles, Subtitle A- Reauthorizations, Subtitle B- Drugs and Biologics, Subtitle C- Medical Devices, Subtitle D- Infant Formula, Subtitle E- Cosmetics and Subtitle F- Cross-Cutting Provisions.
As we have done in the past for significant laws amending the operative food and drug statutes, Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FDORA. The memorandum summarizes each section of FDORA and analyzes the new law’s potential effects on the FDA-regulated industry.
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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