FDA, EMA & Regulator Actions
Regulatory agency guidance, approvals, warning letters, and inspection findings relevant to research operations, with attention to effective dates and what is actually binding versus advisory.
Coverage (20)
- FDA’s 2026 Unified Agenda: Trial Reform Docket
FDA’s July 2026 Unified Agenda lists a dozen new proposed rules on clinical trials, Phase 1 IND, DTC ads, and CRL disclosure beyond the IND pilot.…
- FDA’s Elsa 4.0 and HALO: Sponsor Impact
FDA shipped Elsa 4.0 and the HALO data platform in May 2026 — an internal AI upgrade, not a sponsor-facing one. Here is what changed and what did not.…
- EMA Draft Guidance on Trials During Emergencies
EMA’s draft guidance on running clinical trials during public health emergencies closed for comment April 30, 2026. Finalisation is still pending.…
- FDA RFI: AI-Enabled Early-Phase Trials Pilot
FDA’s April 2026 RFI sought input on an AI-enabled early-phase trials pilot. Comment window closed June 29, 2026 — here’s what it covered.…
- FDA CMC Flexibility for Cell & Gene Therapy
FDA eased CMC expectations for cell and gene therapy BLAs on Jan 11, 2026 — finalized in May, extended to genome editing in June.…
- DETERRENT Act Stalls in the Senate
The House-passed DETERRENT Act would cut the Section 117 foreign-gift threshold to $50,000. A 26-group coalition pushed the stalled Senate bill in May 2026.…
- BIOSECURE Act Becomes Law for Biotech Research
BIOSECURE Act became law Dec 18, 2025 (NDAA Sec. 851), restricting federal contracts and grants tied to designated biotechnology companies of concern.…
- The SAFE Research Act Was Dropped From the FY2026 NDAA: Why the Research Community’s Pushback Succeeded
The SAFE Research Act would have cut federal funding over ‘hostile foreign entity’ ties. University pushback got it struck from the FY2026 NDAA.…
- FDA Commissioner’s National Priority Voucher (CNPV) Pilot Program
FDA’s Commissioner’s National Priority Voucher (CNPV) pilot promises a one-to-two-month review for drugs meeting national health priorities. Here’s how it differs from statutory Priority Review Vouche…
- FDA Revises Draft Guidance on Substantial Evidence of Effectiveness
FDA’s June 22, 2026 revised draft guidance clarifies when a single adequate and well-controlled trial plus confirmatory evidence can satisfy the substantial-evidence-of-effectiveness standard for drug…
- FDA’s 2026 Draft Guidance on Bayesian Methodology in Clinical Trials: What It Sets Out
FDA published draft guidance Jan. 12, 2026 setting expectations for Bayesian primary-analysis designs in drug/biologic trials. Comments closed March 13, 2026.…
- RAPID Coverage Pathway: CMS and FDA’s New Fast Track for Breakthrough Devices
CMS and FDA launched RAPID on April 23, 2026, targeting Medicare coverage within 60-90 days of FDA authorization for breakthrough devices, pausing TCET for new candidates.…
- FDA Finalizes Psychedelic Drug Trial Guidance
FDA’s final guidance sets trial-design rules for psychedelic drug studies, addressing functional unblinding and abuse-potential testing.…
- FDA Finalizes Corticosteroid, OTC Meeting Rules
On July 14, 2026, FDA finalized guidances on generic topical corticosteroid bioequivalence testing and formal FDA meetings for OTC monograph drug sponsors.…
- Rutgers Dean Jacqueline Mattis Faces Ethics Probe Over Payments to Her Own Retreat Company
Rutgers University is investigating whether payments its own units made to Dean Jacqueline Mattis’s writing-retreat company, Easton’s Nook, violate New Jersey conflict-of-interest law. Reported totals…
- Südhof Calls for an ‘FDA for Journals’ at Lindau
Nobel laureate Thomas Südhof told Lindau 2026 that publishing is unregulated, dismissed COPE as self-serving, and urged a government “FDA for journals.”…
- FDA’s Revised Master Protocol Draft Guidance: What Basket, Umbrella, and Platform Trial Teams Need to Know
FDA reopened comment on its master protocol draft guidance in June 2026, adding new basket-trial recommendations. Comments are open through August 24, 2026.…
- FDA Expedited IND Pilot: Comments Due Aug. 24
FDA’s proposed Expedited IND Pilot Program would speed first-in-human trials via Qualified Research Institutions; comments now due Aug. 24, 2026.…
- FDA’s Real-Time Clinical Trials (RTCT) Pilot: Where It Stands in 2026
FDA has initiated two proof-of-concept real-time clinical trials and opened an RFI on a broader RTCT pilot program. Final selection criteria are expected in July 2026, with pilot selections completed …
- Australian Universities Accord Implementation: Where HELP Reform, University Funding, and ATEC Stand in 2026
A 2026 status map of Accord implementation: HELP/HECS reform now law, university funding mid-transition, ATEC on its own legislative track.…
