MHRA
MHRA outlines faster Phase 1 assessment rollout
MHRA published a stepwise implementation programme intended to deliver the first wave 1 regulatory assessment within 14 calendar days for qualifying applications by the end of 2026.
Read the official sourceMHRA
MHRA publishes pharmacovigilance procedures guidance
The new guidance summarizes MHRA’s approach to pharmacovigilance procedures.
Read the official sourceFDA
FDA classifies vascular autograft solution as class II
FDA classified flushing and storage solutions for vascular autografts at room temperature as class II devices subject to special controls.
Read the official sourceFDA
FDA clears a regulatory path for generic osilodrostat
FDA determined that ISTURISA 10 mg tablets were not withdrawn for safety or effectiveness reasons, allowing ANDA approval if other requirements are met.
Read the official sourceFDA
FDA renews antimicrobial drugs committee
The Antimicrobial Drugs Advisory Committee was renewed for two additional years, with its new charter effective through October 7, 2028.
Read the official sourceFDA
FDA renews dermatologic and ophthalmic drugs committee
The Dermatologic and Ophthalmic Drugs Advisory Committee was renewed for two additional years, with its new charter effective through October 7, 2028.
Read the official sourceFDA
FDA seeks advisory committee voting member nominations
FDA requested qualified nominees for current and future scientific, technical, professional, and other voting member vacancies on standing advisory committees and panels.
Read the official sourceWhy this matters
Regulatory affairs teams have several concrete developments to track: MHRA is defining its approach to faster qualifying Phase 1 assessments and pharmacovigilance, while FDA has clarified device controls, generic eligibility, and the continued structure and membership of key advisory committees.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.