Regulatory bodies

In PDUFA reauthorization subgroup meetings, CHPA suggests expanding FDA’s special protocol assessment program to include OTC drug studies before FDA notes Congress has required it to provide switch-specific guidance before current PDUFA expires.

Commissioner Martin Makary told staff that more than 400 new people are being onboarded, although where they will be placed is unclear.

Agency says FY 2026 Tier 1 OMOR fees are $587,529 and Tier 2 fees are $117,505. The fees, due to FDA when an OMOR is filed, aren’t included in OMUFA target revenue calculation for each fiscal year based entirely on annual facility registration fees.

Anvisa, the Brazilian medicines regulator, has published a new Q&A document relating to clinical research requirements. Meanwhile, the regulator’s new innovation committee, set up to monitor and evaluate innovative products, has set out its key priority areas.

MediNatura expands recall to include all lots of both ReBoost and ClearLife nasal sprays after microbial contamination and yeast or mold were found. Firm in 2021 challenged homeopathic drug oversight change from policy in place since 1988.

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.

The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.

With Richard Pazdur’s abrupt exit marking the fifth CDER leadership change in a year, the AAM is urging continuity and stability amid the ongoing turbulence.

Enforcements at facilities in Missouri operated by Shaman Botanicals and Relax Relief Rejuvenate Trading were preceded by administrative detention orders, FDA’s first use of the authority since its reorganization in October 2024.

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.