Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
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
TGA Guidance: General Dossier Requirements
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK
USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment
USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder
EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK
EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants
USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders
USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications
USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area
MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions