FDA, CMS & Regulatory Frameworks
|3 min read
Nora Hess: ‘CLIA Regulations Were Written for an Earlier Time’
Long-time expert discusses the current regulatory environment for clinical labs
|2 min read
CAP Warns CMS Against Broad Lab Fraud Crackdown
Pathologists say aggressive anti-fraud proposals could increase administrative burdens and restrict access to legitimate molecular testing
|2 min read
FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
The FDA has approved Hepcludex, the first treatment for chronic hepatitis D virus infection, offering a new option for patients at risk of severe liver complications
|2 min read
The Bayesian Breakthrough: Transparent AI in Clinical Trials
FDA draft guidance on Bayesian methods is driving more transparent, data-driven clinical trial design
|2 min read
FDA Launches Initiative to Advance Drug Repurposing for Unmet Medical Needs
The agency is particularly focused on new uses to treat chronic or rare diseases, substance use disorders
|2 min read
FDA Announces Major Steps to Implement Real-Time Clinical Trials
Agency unveils real-time trial proofs-of-concept and upcoming pilot program
|2 min read
CMS, FDA Launch RAPID Coverage Pathway for Breakthrough Devices
New regulatory alignment initiative aims to shorten the gap between FDA authorization and Medicare coverage decisions for eligible medical devices
|2 min read
AACR Calls on Congress to Once Again Summarily Reject the President’s Budget Proposal for NIH
The President’s FY2027 budget proposal includes devastating cuts of nearly $6 billion to NIH’s budget for lifesaving research
|3 min read
Implantable ‘Living Pharmacy’ Produces Multiple Drugs Inside the Body
New system generates oxygen, sustaining drug-producing cells for weeks
|2 min read
The Future of Cancer Research Is on the Line—and Young Scientists Know It
AACR sends 20 early-career researchers to Capitol Hill to advocate for NIH and NCI funding
|3 min read
FDA Fast-Tracks Ultra-Rare Therapies with Plausible Mechanism Guidance
Framework enables approval of individualized genome editing and RNA-based treatments when traditional trials aren’t feasible
|5 min read
Medicare Is Experimenting with Having AI Review Claims—a Cost-Saving Measure That Could Risk Denying Needed Care
A new pilot brings some automated treatment decisions from Medicare Advantage to traditional Medicare
|3 min read
