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UK MHRA Guidance: Applying for a Licence to Market a Medicine in the UK
USFDA: CDER Establishes New Center for Real-World Evidence Innovation (CCRI)
USFDA Guidance: Standardized Format for Electronic Submission of NDA and BLA Content for Bioresearch Monitoring (BIMO) Inspections
USFDA Draft Guidance: Accelerated Approval – Expedited Program for Serious Conditions
USFDA Guidance: Enhancing Communication and Guidance Development Practices
UK MHRA Press Release Trials Innovative AI Technologies in Regulatory Pilot Scheme
ICH Seeks Market Consultation for Global Post-Approval CMC Assessment Cloud Solution
EMA Guidance: Scientific Guidelines with Summary of Product Characteristics (SmPC) Recommendations
UK MHRA Issues Final Call to Comply with Windsor Framework for Medicines by January 2025
USFDA: Guidances to Advance Drug Development and Safety Assessments Advance Drug Development and Safety Assessments
Australia's TGA: Listed Medicines Evidence Guidelines
Swissmedic Guidance on Product Information for Human Medicinal Products
UK MHRA Guidance: How Marketing Authorisation Applications referred under Article 29 are Handled
South Africa's SAHPRA: Communication to Industry on Quality Variations
South Africa-SAHPRA: Engagement Portal
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
Australia's TGA Good Clinical Practice (GCP) Inspection Program
USFDA Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025