Article Summary:
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