- Leveraging Prior Knowledge – When Do Sponsors Not Have to Recreate the Wheel? Breaking Down FDA’s New Draft Guidance From a Nonclinical and Clinical Perspective June 12, 2026
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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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- Leveraging Prior Knowledge – When Do Sponsors Not Have to Recreate the Wheel? Breaking Down FDA’s New Draft Guidance From a Nonclinical and Clinical Perspective June 12, 2026
- WuXi AppTec’s 1260H Listing Brings the BIOSECURE Act Back to Center Stage June 10, 2026
- Long Live the Skinny Label June 7, 2026
- HPM Announces Firm and Attorney Selection for 2026 Chambers USA Guide June 5, 2026
- FDA Issues Final Guidance for Content of Human Factors Information in Medical Device Submissions June 3, 2026
- 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