In The News
AgencyIQ – FDA finishes work on a new guidance on accelerated approval for oncology products
Regulatory Background What is the Office of Information and Regulatory Affairs (OIRA)? OIRA sits within the White House Office of Management and Budget (OMB), where it serves
Bio-IT World – Pharma-Diagnostics Lockstep: How Two Industries Can Work Together for Precision Medicine
Sarah Hersey, VP of Precision Medicine at Bristol Myers Squibb, gave a balanced view of the challenges and opportunities facing precision medicine in her keynote
The Cancer Letter – Mark Smith, cancer advocate and healthcare policy expert, dies at 63
For those to whom the name doesn’t ring a bell, Mark spent the majority of his 35-year career working to fund and further the goals
Pink Sheet – US FDA Cell/Gene Therapy Office ‘Aggressively Recruiting’ Amid Reorg, Senior Staff Departures
Center for Biologics Evaluation and Research Director Peter Marks wants people to come work at the US Food and Drug Administration, but he also understands
Dark Daily – Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests
Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge
Regulatory Focus – This Week at FDA: FDA names new Office of Compliance, CVM directors
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device
New Friends of Cancer Research Manuscript Furthers Work in Aligning Disparate Real-World Data in Oncology
A new manuscript by Friends of Cancer Research (Friends) published today in JCO Clinical Cancer Informatics, details a framework to align electronic patient reported outcome
Pink Sheet – US FDA Advisory Committees’ Future: Drug-Agnostic Panels, More Debate Time
US Food and Drug Administration Commissioner Robert Califf wants advisory committees spending more time debating drug development topics that apply to multiple products, rather than
Pink Sheet – US FDA Has People Working At CMS To Help Implement Inflation Reduction Act
The US Food and Drug Administration now has employees working at the Centers for Medicare and Medicaid Services as part of the increased collaboration spurred
Pink Sheet – Gene Therapy: Years After Accelerated Approval, Will US FDA Still Be Asking ‘Does It Work?’
Accelerated approval is likely to be used more extensively in the future for gene therapies that treat very rare diseases, but the slowly progressive nature
