Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
Australia TGA: Clinical Evidence Guidelines
Swiss Medic: Biosimilar Authorisation Guidance
USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports
South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments
USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model
UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process
Switzerland's SwissMedic: Guidance on Formal Requirements
USFDA Guidance: Real-Time Oncology Review (RTOR)
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers
USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption