FDA
- Bioanalytical Method Validation for Biomarkers (Final Guidance)
- Notice: Guidance: Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing (Federal Register)
- Rule: Medical Devices: Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion (Federal Register)
- Rule: Medical Devices: Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant (Federal Register)
- Rule: New Animal Drugs: Approval and Withdrawal of Applications; Change of Sponsor; Change of Sponsor Address (Federal Register)
- Rule: Physical Medicine Devices: Reclassification of Non-Invasive Bone Growth Stimulators (Federal Register)
- Notice: Guidance: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1) (Federal Register)
- FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development (Press Release)
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Final Guidance)
- FDA Takes Step Forward on Testosterone Therapy for Men (Press Release)
NIH
- NIH-funded breakthrough shrinks CRISPR for precision delivery in the body (Intramural News)
- What Should I Know About the Current and Pending (Other) Support (CPOS) Common Form? (Extramural News)
- So, I’m Interested in a Highlighted Topic…What Do I Do Now? (Extramural News)
- NOT-OD-26-069: Continuation of Modifications to Peer Review Practices (Policy Notice)
HHS
- Proposed Rule: Medicare and Medicaid Programs: Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, etc. (Federal Register)
- HHS Announces $4 Million KidneyX EMPOWER Prize Challenge and Health Technology Project to Advance Living Kidney Donation and Patient-Centered Innovation (Press Release)
GAO
- Artificial Intelligence Acquisitions: Agencies Should Collect and Apply Lessons Learned to Improve Future Procurements
- Technology Transfer: Funding Recipients Keep Most Federally Funded Inventions, but Some Cited Reporting Challenges
- Grants Management: Efforts to Address Challenges Through Government-wide Collaboration
- Congressional Review Act: Agencies and Congress Could Improve Implementation of 60-Day Delay for Major Rules
Other News
- Congressional Bills S. 1884 and S. 3971 Signed into Law (White House News)
- NEXT WEEK: Senate HELP Committee to Hold Hearing with Secretary Kennedy on HHS Budget (Press Release)
- Chairman Cassidy Unveils Agenda to Make Health Care Affordable Again (Senate HELP Press Release)
- Investigations and Oversight Subcommittee Hearing – The State of Scientific Publishing: Assessing Trends, Emerging Issues, and Policy Considerations (Committee on Science, Space, and Technology)
- Two U.S. Nationals Sentenced for Facilitating Fraudulent Remote Information Technology Worker Scheme that Generated $5M in Revenue for the Democratic People’s Republic of Korea (DOJ Press Release)
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