TGA Guidance: General Dossier Requirements
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
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
USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
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