PV Bulletin

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Food and Drug Administration

publicFood and Drug Administration · United States · Updated Jul 13, 2026

Psychedelic Drugs: Considerations for Clinical Investigations

Urgency: High

Clinical safety and pharmacovigilance teams must implement new safety monitoring protocols and ensure adequate assessment of abuse potential as stipulated in the guidance.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Guideline
Read impact briefarrow_forward
publicFDA · United States · Updated Jul 13, 2026

Formal Meetings Between the FDA and Sponsors of OTC Monograph Drugs

Urgency: High

Sponsors must adhere to defined meeting types (Type X, Y, Z) and submit meeting packages at least 3 months before planned submissions for OTC monograph drugs, ensuring FDA engagement occurs within set timelines.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Guideline
Read impact briefarrow_forward

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