ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
Health Canada: Guidance on Nitrosamine Impurities in Medications
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API
UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication
Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Pakistan's DRAP: Guidelines for Good Cold Chain Management Practices
USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
Swissmedic: Guidance for Requesting Product Certificates (Certificate of a Pharmaceutical Product)
Swissmedic: eCTD v4.0 Implementation Guide published
USFDA Guidance: Pharmacogenomic Data Submissions
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A