The Top Line17 Okt 2025

Unpacking the FDA transparency push on CRLs

The FDA made waves in early September when it announced a plan to publicly release complete response letters (CRLs) at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency.”

At the same time, the FDA released 89 new CRLs, adding to the more than 200 that were previously made public in July and shedding more light on the agency’s often opaque review process. That earlier document dump, though, only included rejection letters for drugs that were eventually approved. Now, for the first time, the agency is releasing CRLs for unapproved drug candidates—including recent high-profile rejections such as Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug.

Publicly airing the rationale for rejecting drug candidates is a significant shift for the FDA and a potential cause for concern for the biopharma industry.

To unpack what the new policy means for drug developers, Fierce Biotech’s Darren Incorvaia sat down with Torrey Cope, a lawyer with Sidley Austin who represents and advises life sciences companies on issues related to the FDA.

To learn more about the topics in this episode:

FDA releases ‘initial batch’ of more than 200 drug rejection letters

FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub

FDA misinterpreted efficacy data that prompted DMD rejection, Capricor claims

‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

'Several concerning observations': FDA sheds more light on reasons it rejected drugs

See omnystudio.com/listener for privacy information.

Denne episoden er hentet fra en åpen RSS-feed og er ikke publisert av Podme. Den kan derfor inneholde annonser.

Episoder(100)

How we picked the Fierce 15

What does it mean to be a Fierce 15 biotech in 2026? With this year’s list unveiled, the Fierce Biotech team gets together to discuss what the winners tell us about the state of the sector.In this wee...

9 Okt 23min

Locking in on pharma’s consumerization trend

With GLP-1s paving the way, a consumer shift is happening across markets for certain branded pharmaceuticals. Now, the CEO of a buzzy pattern-hair-loss biotech is eyeing opportunities in an evolving m...

2 Okt 18min

Fierce Pharma Week: A look at the biggest trends, campaigns and conversations

Fierce Pharma Week brought thousands of people to Philadelphia for four days of conversations about pharma marketing, commercialization, medical affairs and communications. In this episode of "The Top...

25 Sep 24min

Inside the growing world of biopharma prediction markets

Prediction markets are opening up new ways to bet on biopharma events, from clinical trial readouts to FDA approvals. But they also create a new set of risks for an industry where employees, researche...

18 Sep 23min

Clinical trials reach a new automation inflection point (Sponsored)

Clinical development organizations are facing mounting pressure to do more with increasingly complex protocols, larger data sets and tighter timelines. While automation has improved individual process...

14 Sep 17min

The future of RAS inhibitors

Revolution Medicines recently made history with the approval of its RAS inhibitor Rasonque for advanced pancreatic cancer. But behind RevMed is an entire field of biotechs working to broaden the reach...

11 Sep 29min

The people who stayed with the problem

The 2026 Fierce 50 includes people and organizations working on very different problems across biopharma and healthcare, from designing new proteins and developing cancer medicines to protecting vacci...

4 Sep 25min

Why Diagnostic-Driven Therapies Still Miss Eligible Patients (Sponsored)

The promise of precision medicine depends on more than scientific innovation. It also depends on whether eligible patients can be identified, tested and connected to the most appropriate treatment. In...

2 Sep 13min