This week’s FDA updates focus on regulatory reforms, product approvals, and safety recalls. Commissioner Marty Makary announced a pilot program offering bonuses to drug reviewers who complete work ahead of schedule, with initial payments beginning in August. Makary also defended CBER Director Vinay Prasad against media criticism, asserting he’s selecting the best scientists regardless of political backgrounds.

The agency published meeting minutes for ongoing user fee negotiations (GDUFA IV, PDUFA VIII, MDUFA VI) and released guidance on protecting confidential commercial information. FDA’s Division of Applied Regulatory Science reported completing 49 research projects and numerous collaborations in 2025.

**Key Drug Approvals:**
– Boehringer Ingelheim’s Hernexeos received accelerated approval for non-small cell lung cancer in just 44 days under the new Commissioner’s National Priority Voucher program
– Pfizer’s Braftovi gained approval for metastatic colorectal cancer with BRAF mutations
– Sanofi/Regeneron’s Dupixent became the first FDA-approved treatment for allergic fungal rhinosinusitis

**Medical Device Updates:**
CDRH reported improved performance metrics, with first-cycle major deficiency letters decreasing from 82% to 74%. However, several serious safety recalls were announced:
– Fresenius Kabi’s Ivenix pump (Class I recall for software anomalies)
– Boston Scientific’s Axios stents (167 injuries, 3 deaths reported)
– Olympus’s High Flow Insufflation Units (software overpressure issues)
– Abiomed’s Impella devices (purge leak risks)

FDA announced plans for 85 new drug-specific guid

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The post This Week at FDA: Speedy Drug Review Bonuses, Makary Defends Prasad, and More first appeared on FDA Learning Cache.

FDA Commissioner Marty Makary wants the same sense of urgency applied to the agency’s Commissioner’s National Priority Voucher (CNPV) program as was seen with Operation Warp Speed’s COVID-19 vaccine development. The CNPV program aims to expedite reviews of the chemistry, manufacturing, and controls (CMC) portion of drug submissions while therapies are still in clinical trials. Makary likened this to the efficiency of Operation Warp Speed, stating the agency should challenge assumptions that drug development takes 10-12 years and that manufacturing must be done outside the US.

Makary also discussed the FDA’s PreCheck program, which will designate its first company this summer. This program is intended to streamline oversight of certain manufacturing facilities based on national priorities, provide regulatory predictability, and encourage domestic factory construction.

Regarding technological innovations, Makary highlighted the agency’s use of AI to expedite application processing and reduce the need for animal testing. He noted FDA’s ELSA AI assistant and how computational modeling can predict drug interactions, potentially shaving 6-9 months off development timelines. The FDA has also loosened animal testing requirements for monoclonal antibodies and other drugs, instead relying on real-world data and New Approach Methodologies.

Lastly, Makary said the FDA is updating guidance to ease oversight of general wellness devices and clinical decision support software, allowing the agency to “get out of the way” for consumer-grade products while maintaining oversight for medical-grade devices.

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The post Makary’s Priorities: Faster Reviews, Domestic Manufacturing, and AI first appeared on FDA Learning Cache.

The Trump administration’s appointment of Dr. Tracy Beth Høeg, a vaccine skeptic, as the acting director of the FDA’s Center for Drug Evaluation and Research has raised alarm among senior FDA officials. They fear Høeg’s lack of experience in drug review and her controversial views on vaccines will harm the agency’s reputation as a reliable regulator of the nation’s drug supply.

Høeg has advocated for making it more difficult for young men to receive the COVID-19 vaccine due to the potential risk of myocarditis. She has also helped write a memo claiming that the FDA has found at least 10 children died “after and because of” receiving the COVID-19 vaccine, a claim not supported by data. This memo proposed changes to how the FDA handles COVID-19 and other vaccines, which former FDA leaders have denounced as undermining the agency’s role in ensuring vaccine safety and effectiveness.

In her new role, Høeg will oversee the office responsible for approving new drugs and ensuring the safety and effectiveness of all over-the-counter and prescription drugs in the U.S. Senior FDA officials fear she will politicize this science-focused office, leading companies to view the FDA as an unreliable partner and potentially choose to develop new products overseas.

The appointment comes after the abrupt resignation of a veteran FDA scientist, Richard Pazdur, who clashed with FDA Commissioner Marty Makary. Høeg’s selection as acting director is seen by some as an “extinction-level event” that will lead to further resignations within the agency.

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