Regulatory Blog

Swiss Medic: Biosimilar Authorisation Guidance

USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports

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 Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption

TGA Guidance: General Dossier Requirements

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

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