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Selling Sentinel: FDA Highlights Vision For Broader Role For Data Network At Brookings

 
• By Jacqueline Fitton and Michael McCaughan

FDA’s Janet Woodcock used her time at a conference on biomedical innovation to highlight ways to use FDA’s Sentinel network more broadly to standardize, and hopefully streamline comparative effectiveness research.

The Food & Drug Administration’s role in biomedical innovation has, historically at least, been defined in pretty narrow terms: FDA is the gatekeeper. Until a new technology meets FDA’s standards for safety and efficacy, it can’t be marketed.

That is a powerful and important role, to be sure. But, fundamentally, a negative one: FDA’s job is to say...

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More from Post-Marketing Regulation & Studies

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 
• By Derrick Gingery and Mandy Jackson

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 
• By Sarah Karlin-Smith

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

More from Product Reviews

Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues

 
• By Sue Sutter

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.