Regulatory Blog

The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...

The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be...

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which...

The guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product...

The International Coalition of Medicines Regulatory Authorities (ICMRA) and World Health Organisation (WHO) calls on the pharmaceutical...

What is a Biosimilar Medicine? Biosimilar medicine is a biological medicine that is developed to be highly similar and clinically...

The purpose of this guidance is to illuminate any challenging areas lacking solutions to sufficiently ensure trial participant's safety...