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Sep 20, 20221 min read

UK MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)

The UK MHRA released this updated guidance today and added a section on 'Advertising and promotions' to Northern Ireland MHRA Authorised...

Jun 18, 20221 min read

Philippines FDA - Guidelines on Abridged and Verification Review Pathways for New Drug Registration

Abridged review refers to a limited independent assessment of specific parts of the dossier, or submission for suitability of use under...

Mar 6, 20221 min read

MHRA adds Health Technology Assessments (HTA) Tool Details to ILAP Guide

MHRA, the UK Medicines and Healthcare Products Regulatory Agency has updated its guidance information on the Innovative Licensing and...

Feb 6, 20221 min read

USFDA Guidance on Premarket Review of Combination Products

US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways...