Demystifying the US IND process for initiation of clinical trials
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a…
Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene…
In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
FDA Meeting Series: How, When and What – INTERACT Meetings
INTERACT Meetings What: CDER is now also accepting INTERACT Meetings. Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT)…
Innovative Marketing Authorization Transfer Preserves Vital Patient Supply
The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment…
FDA Meeting Series: How, When and What – EOP Meetings
End-of-phase (EOP) meetings occur when development has reached the end of a particular phase and is ready to move to…
FDA Meeting Series: How, When and What – pre-IND Meetings
pre-IND Meetings What: pre-Investigational New Drug application (pre-IND) meetings are formal PDUFA Type B meetings held between a sponsor…
FDA Meeting Series: How, When and What – General Introduction
The Food and Drug Administration (FDA) offers sponsors many opportunities for interaction and guidance during the course of drug development…
Regulatory pathway and agency interaction: The EU vs the US
The introduction of a new medicinal product to the US and European market follows a complex process that may extend…