Clinical research and clinical trials

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.

HHS OIG is asking whether the Anti-Kickback Statute needs a new safe harbor for paying clinical trial participants. Comments on the RFI are due August 24, 2026.

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EMA’s draft guidance on running clinical trials during public health emergencies closed for comment April 30, 2026. Finalisation is still pending.

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.

NIH plans to widen All of Us pediatric enrollment to ages 0-12 in 2026, even as the program absorbs a steep funding drop from FY2023 levels.

FDA eased CMC expectations for cell and gene therapy BLAs on Jan 11, 2026 — finalized in May, extended to genome editing in June.

The EU’s proposed Biotech Act (Commission proposal adopted 16 December 2025, not yet enacted) would revise Clinical Trials Regulation Article 93 to align it with GDPR, naming sponsors and investigators as data controllers and permitting cross-trial data reuse — here is what is actually proposed, what the EDPB-EDPS flagged as unresolved, and what remains to be decided.

An FDA warning letter dated July 10, 2026, cites a bioequivalence-trial investigator tied to an Alembic Pharmaceuticals facility for obtaining informed consent after study procedures had already begun. Here is what the letter actually says, and what unverified secondary claims about it do not hold up.

ARPA-H’s Advancing Clinical Trial Readiness (ACTR) initiative aims to put a clinical trial site within 30 minutes of 90% of eligible Americans. Here’s what the program covers, its three funding focus areas, and where it stands.

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 Vouchers, who has received one, and where the program stands as of FDA’s 2026 public hearing.

Health Canada’s draft Clinical Trials Regulations and its April 2026 ICH E6(R3) adoption mark Canada’s biggest trial-oversight overhaul in decades.

FDA’s June 22, 2026 revised draft guidance clarifies when a single adequate and well-controlled trial plus confirmatory evidence can satisfy the substantial-evidence-of-effectiveness standard for drug and biologic approval, narrowing the traditional two-trial default. Comments are open through September 22, 2026.

FDA published draft guidance Jan. 12, 2026 setting expectations for Bayesian primary-analysis designs in drug/biologic trials. Comments closed March 13, 2026.

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’s final guidance sets trial-design rules for psychedelic drug studies, addressing functional unblinding and abuse-potential testing.

On July 14, 2026, FDA finalized guidances on generic topical corticosteroid bioequivalence testing and formal FDA meetings for OTC monograph drug sponsors.

CMS’s CY2027 fee schedule proposal narrows, not bans, third-party RPM/RTM billing. Here is the real mechanism, the OIG data behind it, and what it means for clinical trial billing compliance.

AHRQ has issued near-identical “non-award” letters ending continuation funding for dozens of active grants, citing portfolio prioritization. HHS says these are not terminations; grantees and advocacy groups disagree, a distinction with real consequences for appeal rights and sponsored-programs planning.

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’s proposed Expedited IND Pilot Program would speed first-in-human trials via Qualified Research Institutions; comments now due Aug. 24, 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 in August 2026.

ClinicalTrials.gov is retiring the Classic Protocol Registration and Results System (PRS) in stages through 2026 and 2027, moving every sponsor and registrant onto the Modernized PRS. Here is the confirmed timeline, from the July 2026 cutoff on new records to the Fall 2026 submission deadline, and what to do before each one.