hotspot -WSS

hotspot

author：explore 2025-08-06 04:47:11 - browse：8626

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： Peter Hotez and the public health issue of online harassment
Next article： What the airline industry can learn from medicine

WSS

What the airline industry can learn from medicine

Listen: Biogen's situation, Wegovy's risks, & biotech insider trading

Criminal prosecution for violating HIPAA: an emerging threat

Canadian Prime Minister Justin Trudeau separating from wife, Sophie

What the US credit downgrade means for the economy, your finances

Bird flu: Don't repeat Covid's 'health versus the economy' framing

focus

hotspot

leisure time

As demand for Covid shots wanes, Moderna seeks its next success

How a billionaire couple greased the skids for Pelosi’s drug pricing bill

Novavax promises a turnaround & Lilly roils the obesity market

With measles on the rise, a personal story of a devastating disease

What does generative AI mean for health care? We asked experts

When prostate cancer spreads, where it goes matters

Medical records are filled with copy

When prostate cancer spreads, where it goes matters

Dobbs anniversary: the lost opportunity of abortion as health care

Wildfire pollution widens asthma inequities on Long Island

focus

Arc Institute generative AI designs new CRISPR systems

Analysis of pharma R&D ranks Novo Nordisk, J&J above their peers

‘Oppenheimer’ and the risks of AI in health care

‘Oppenheimer’ and the risks of AI in health care

With measles on the rise, a personal story of a devastating disease

With measles on the rise, a personal story of a devastating disease

explore

explore

hotspot

Wikipedia