Category: Standards

USA: FDA Revises Guidance on Post marketing Studies and Clinical Trials

October 25, 2019
Standards

The US Food and Drug Administration (FDA) revised its draft guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21...

EU: EC Offers New Site Suitability Template under Incoming Clinical Trial Regulation

October 23, 2019
Standards

The European Commission (EC) published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which...

Regulatory CMC Changes – Challenges and Management

August 30, 2019
Standards

CHALLENGES: Abiding by the national laws and regulations is a necessity for biopharma organizations towards the development, manufacture and selling of their pharmaceutical products. Prior...

Luxembourg and The Netherlands benefit from the EU-US Mutual Recognition Agreement for Inspections

June 26, 2019
Standards

Luxembourg and the Netherlands were added into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). FDA confirms the ability of...