

- 3 days ago
- 2 min
Swiss Medic: Biosimilar Authorisation Guidance


- 5 days ago
- 2 min
USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports


- Nov 18
- 2 min
UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process


- Nov 15
- 2 min
Switzerland's SwissMedic: Guidance on Formal Requirements


- Nov 11
- 2 min
USFDA Guidance: Real-Time Oncology Review (RTOR)


- Nov 7
- 1 min
MHRA Guidance: Common Issues Identified during Clinical Trial Applications


- Nov 6
- 2 min
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation


- Nov 2
- 1 min
USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption


- Oct 31
- 1 min
TGA Guidance: General Dossier Requirements


- Oct 25
- 1 min
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities


- Oct 23
- 1 min
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices


- Oct 23
- 2 min
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products


- Oct 21
- 2 min
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation


- Oct 21
- 1 min
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK


- Oct 17
- 2 min
USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment


- Oct 14
- 1 min
USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder


- Oct 14
- 1 min
EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure


- Oct 14
- 2 min
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK


- Oct 10
- 2 min
EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants


- Oct 6
- 1 min
USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders