Clinical trial disclosure
Clinical trial disclosure requirements are creating a secondary compliance burden for Trade and Geopolitical Risk teams, particularly where cross-border data sharing, export-controlled research, and foreign government-sponsored trials intersect with sanctions regimes. The U.S. Food and Drug Administration's 2023 final rule on clinical trial data submission under 42 CFR Part 11, combined with oversight activity from the European Medicines Agency and the U.S. Department of Health and Human Services Office for Human Research Protections, means disclosure obligations now touch supply chain provenance, foreign principal relationships, and technology transfer in ways most risk functions have not fully mapped. Cresthaven tracks every relevant agency action across this intersection so compliance teams are not reconstructing the picture from scratch.
Watch
- 42 CFR Part 11 final rule: deadline compliance for foreign-site trial registrations
- EMA transparency policy on trials conducted in sanctioned-country research facilities
- HHS OHRP guidance on foreign government co-sponsorship disclosure requirements
- Dual-use research of concern disclosures flagged in ClinicalTrials.gov filings
- BIS export control overlap with biologics trial data shared to APAC affiliates
Recent material activity in Trade & Geopolitical Risk
A selection of recent published briefs; this is not a complete archive.
CBP Cargo Systems Messaging Service (CSMS) release pending Cresthaven Analytics full analysis: CSMS # 70015464 - Information: Quota Bulletin 26-305 2027 Specialty Sugar
CBP Cargo Systems Messaging Service (CSMS) published a regulatory release titled 'CSMS # 70015464 - Information: Quota Bulletin 26-305 2027 Specialty Sugar'. Cresthaven Analytics' full intelligence brief is pending re-an…
Read a full sample brief →OFAC Enforcement & Recent Actions (direct) release pending Cresthaven Analytics full analysis: Publication of Regulatory Amendments; Publication of Report for Licensing Activities Undertaken Pursuant to the Trade Sanctions Reform and Export
OFAC Enforcement & Recent Actions (direct) published a regulatory release titled 'Publication of Regulatory Amendments; Publication of Report for Licensing Activities Undertaken Pursuant to the Trade Sanctions Reform and…
Read a full sample brief →CBP opens 2027 refined sugar tariff-rate quota on October 1, 2026, with oversubscription expected at opening moment
CBP published Quota Bulletin 26-301 on September 24, 2026, establishing the tariff-rate quota for refined sugar for the period October 1, 2026 through September 30, 2027. The quota opens at 12:00 P.M. Eastern Time on Oct…
Read a full sample brief →CBP publishes 2027 quota bulletin for sugar-containing products with October 1 opening date
CBP issued Quota Bulletin 26-304 on September 24, 2026, establishing tariff-rate quota parameters for sugar-containing products under Harmonized Tariff Schedule Chapters 17, 18, 19, and 21 for the quota year running Octo…
Read a full sample brief →USITC opens public interest comment period for Section 337 complaint targeting wearable health monitoring devices
The U.S. International Trade Commission received a complaint on September 24, 2026 targeting certain wearable activity and health monitoring devices and systems containing them, docketed as DN 3937. The Commission now so…
Read a full sample brief →USITC issues affirmative injury determinations on perfluoroalkoxy alkane imports from India
The USITC published final injury determinations on September 24, 2026 covering perfluoroalkoxy alkane (PFA) from India, completing the injury phase of the investigation and clearing the way for permanent antidumping and …
Read a full sample brief →ITC issues general exclusion order barring all imports of patented absorption refrigeration boiler protection systems
The U.S. International Trade Commission issued a final determination on September 24, 2026, finding a violation of Section 337 of the Tariff Act of 1930. The Commission issued a general exclusion order prohibiting all im…
Read a full sample brief →USITC reviews Section 337 violation finding in flash-spun nonwoven materials investigation and solicits remedy submissions
The USITC issued a notice on September 24, 2026 announcing a partial review of an administrative law judge's final initial determination that found a Section 337 violation in flash-spun nonwoven materials. The Commission…
Read a full sample brief →USITC reviews Section 337 violation finding in LCD glass substrate investigation, opens remedy and bonding submissions
The USITC issued a notice on September 24, 2026, announcing partial review of an administrative law judge's July 23, 2026 final initial determination, which found a Section 337 violation in an investigation covering glas…
Read a full sample brief →ITC institutes Section 337 investigation into wearable breast pump imports on five Willow patent claims
The U.S. International Trade Commission instituted a Section 337 investigation on September 24, 2026, based on a complaint filed by Willow Innovations, Inc. and Willow Blossom HoldCo Ltd. The complaint alleges patent inf…
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