Healthcare & Life Sciences
FDA CBER, FDA CDRH, CMS, EMA, ECDC, MHRA, EU HTA, PMDA, HSA, TGA — biologics, medical-device, and reimbursement intelligence for pharma, biotech, and digital health.
US
- FDA + DEA DEA issues notice of intent to temporarily place O-desmethyltramadol in Schedule I of the Controlled Substances Act Read sample brief →
- FDA CBER FDA issues Warning Letter to Estar Technologies Ltd for IDE and PMA adulterated device violations Read sample brief →
- FDA CDRH FDA issues Early Alert for Draeger anesthesia workstation recall over ventilator failure risk Read sample brief →
- CMS via Federal Register API CMS final rule tightens Medicare accrediting organization oversight, conflict-of-interest rules, and reentry limits for terminated providers Read sample brief →
EU
- European Medicines Agency EMA CHMP recommends EU marketing authorisation revocation for Tavneos following GCP breach finding in pivotal trial Read sample brief →
- Medicines & Healthcare products Regulatory Agency MHRA grants UK marketing authorisation for nipocalimab (Imaavy) in generalised myasthenia gravis Read sample brief →
- European Commission SANTE European Commission publishes joint clinical assessment report on tovorafenib for pediatric low-grade glioma Read sample brief →
- European Centre for Disease Prevention & Control ECDC and EFSA publish joint HPAI A(H5) overview covering 949 detections across 30 European countries from March to May 2026 Read sample brief →
APAC
- Therapeutic Goods Administration TGA issues safety alert on FluMist age-range administration errors in children under 2 years Read sample brief →
- Pharmaceuticals & Medical Devices Agency PMDA and MHLW issue revised drug package insert precautions following new risk identification Read sample brief →
- Health Sciences Authority HSA Singapore identifies undeclared potent corticosteroid in herbal product linked to iatrogenic Cushing's Syndrome Read sample brief →
Frequently asked
Is Cresthaven Analytics good for clinical-stage biotech and small biotech funds?
Yes — designed for biotech fund analysts, regulatory affairs heads, GCs at clinical-stage biotech, hospital compliance teams, and medical-device operators. Covers 11 healthcare agencies: FDA CDER, FDA CBER, FDA CDRH, CMS, EMA, MHRA, EU SANTE, ECDC, TGA, PMDA, HSA. Material approvals, advisory committee actions, safety signals, and guidance updates arrive as structured briefs within minutes. Professional at $399/month covers 6 agencies including FDA CDER + CBER + CDRH + EMA + MHRA + CMS.
What FDA centers and EU regulators does Cresthaven Analytics cover for biotech?
FDA CDER (drugs), FDA CBER (biologics including gene therapy), FDA CDRH (medical devices), CMS (Medicare/Medicaid coverage decisions), and the EU equivalents: EMA, MHRA, EU SANTE, EU HTA Coordination Group, ECDC. APAC: PMDA (Japan), TGA (Australia), HSA (Singapore). Each agency feeds structured briefs covering approvals, CRLs, advisory committee actions, safety alerts, and guidance documents.
What's the cheapest Cresthaven tier for biotech regulatory monitoring?
Basic at $149/month covers 3 agencies. A typical biotech setup is FDA CDER + FDA CBER + EMA for cross-jurisdictional pharma. Add CDRH ($29/month) for medical-device coverage, MHRA for UK exposure, or CMS for reimbursement intelligence. For a biotech fund covering both pharma and medical devices, Professional at $399/month covers 6 agencies with daily digests and cross-agency synthesis.
How does Cresthaven Analytics compare to Clarivate Cortellis or Pink Sheet for biotech regulatory intelligence?
Clarivate Cortellis and Citeline Pink Sheet are deep-database products: structured regulatory records, trial intelligence, decades-long historical archives, often priced $15,000 to $40,000 per year for small-team licenses. Cresthaven Analytics is a focused brief-delivery service: structured executive briefs delivered by email and portal, source-linked, at $149 to $999 per month. Cresthaven covers what changed and what it means; Cortellis and Pink Sheet are the right choice if you need a deep searchable database of historical regulatory records.
Built for your role
Persona-specific intelligence pages covering individual agencies in this sector.
Regulators we track in this sector
Every regulator below has its own coverage page with recent material activity and a worked example of how we structure each brief.
Topics in this sector
A sample of the cross-regulator topics we track in this sector. Each topic page follows how material activity develops across every regulator that touches it.
- AI model risk management
- Algorithmic accountability disclosure
- Anti-Money Laundering compliance programs
- Antitrust merger review
- Audit committee requirements
- Beneficial ownership reporting
- Beneficial ownership transparency
- Best execution
- Buy American Act compliance
See all 50 topics
- Capacity market participation (FERC Order 2222)
- Clinical trial disclosure
- Compliance training and certification
- Content moderation compliance
- Controlled Unclassified Information handling
- Country-by-country tax reporting
- Critical mineral supply chain compliance
- Cross-border data transfer compliance
- Custody of customer assets
- Cybersecurity incident disclosure
- Cybersecurity Maturity Model Certification
- Data breach notification
- Defense Federal Acquisition Regulation Supplement
- Drug pricing transparency
- Electric grid reliability (NERC CIP)
- ESG and climate disclosure
- Export Administration Regulations compliance
- Foreign Corrupt Practices Act
- Foreign direct investment CFIUS review
- Foreign Military Sales restrictions
- Form ADV disclosures
- HIPAA privacy and security
- Insider trading surveillance
- Internal controls over financial reporting
- International Traffic in Arms Regulations compliance
- Investment Adviser Marketing Rule
- Know Your Customer verification
- Medical device cybersecurity
- OFAC compliance
- Pharmaceutical advertising compliance
- Pipeline safety and PHMSA compliance
- Recordkeeping and document retention
- Renewable energy certificate tracking
- Sanctions screening
- Section 230 platform liability
- Software Bill of Materials requirements
- Suspicious activity reporting
- Tariff and customs classification
- Third-party risk management
- Vendor cybersecurity due diligence
- Whistleblower program compliance