- FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule December 17, 2024
- FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2) December 16, 2024
- Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules December 13, 2024
- After a Hiatus, the BLOCKING Act is Back! December 11, 2024
- Reminder: HPM and Riparian to Co-Host Webinar on CMS Misclassification Penalties Rule December 11, 2024
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As expected, Donald Trump has signed the Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839), which, among other things, amends the Medicaid Drug Rebate statute to impose penalties for misclassifying innovator drugs as non-innovator drugs to reduce rebates. We previously posted on this law when it passed the Congress on April 2 (see our previous post here). The law is effective as of April 18, the date of enactment.
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- FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule December 17, 2024
- FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2) December 16, 2024
- Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules December 13, 2024
- After a Hiatus, the BLOCKING Act is Back! December 11, 2024
- Reminder: HPM and Riparian to Co-Host Webinar on CMS Misclassification Penalties Rule December 11, 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