hotspot -WSS

hotspot

author：knowledge 2025-10-01 22:16:29 - browse：154

Peter Marks, Director of the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA), testifies during a Senate Health, Education, Labor and Pensions Committee hearing to discuss the on-going federal response to Covid-19 on May 11, 2021 at the US Capitol in Washington, DC. — FDA's Peter Marks JIM LO SCALZO/POOL/AFP via Getty Images

WASHINGTON — The Food and Drug Administration needs dozens more reviewers if it wants its so-called Operation Warp Speed for rare disease therapies to take off, the agency’s biologics chief said Monday.

The administration launched the rare disease pilot program, dubbed START and modeled after the record race for a Covid-19 vaccine, this September. Peter Marks, head of the Center for Biologics Evaluation and Research, has spearheaded both initiatives.

“If we were really to expand this significantly, [it] would require us to get dozens of additional staff members,” Marks told listeners during a gene therapy discussion hosted by the Alliance for a Stronger FDA. “One could say ‘Oh my goodness, he’s asking for more headcount again.’ Well, if this really does reduce the time to development by 25 to 50% … it probably won’t take industry too long to do a net present value calculation to say ‘Oh, it’s worth making sure that they have their extra 20 or 30 or 40 reviewers.’”

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Hepatitis C has a cure — but many Americans still lack access to it
Next article： Resistance to opioid

WSS

Congress considering partial increase for doctor pay in Medicare

Eli Lilly reports tirzepatide MASH success during Q4 earnings

Will.i.am, Britney Spears release new single, 'Mind Your Business'

Congress must protect the remaining independent doctors

Russian special forces kill a gunman who broke into a private house near Moscow

Will.i.am, Britney Spears release new single, 'Mind Your Business'

hotspot

hotspot

entertainment

After affirmative action ruling, medical educators look to 'holistic review'

White House launches permanent pandemic office

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

Caitlin Bernard's story shows physicians can't shy from advocacy

At least 13 dead in Texas as scorching temps continue

Amylyx and the next ALS drug test, plus a chat with CRISPR's CEO

Guidelines to prevent youth baseball injuries need more muscle

Marvel Studios reveals new trailer for 'The Marvels': Watch here

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

Why Eli Lilly’s earnings didn’t quite live up to the hype

Wikipedia

Elizabeth Warren probes abortion access

Sick patients collapsed waiting for care at Massachusetts hospital with known safety violations

Caitlin Bernard's story shows physicians can't shy from advocacy

Tome Biosciences co

Lilly to acquire Dermira for $1.1 billion, adding eczema drug to its pipeline

Latigo launches with $135 million for Vertex

hotspot

focus

Wikipedia

entertainment