Case study
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…
blog
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…
blog
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…
blog
FDA Meeting Series: How, When and What – INTERACT Meetings
INTERACT Meetings What: Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) meetings are informal meetings held between sponsors…
blog
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…
webinar
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…
blog
FDA Advisory Committee Meeting on Toxicity Risks of AAV Vector-Based Gene Therapy Products: a CMC…
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) held a meeting on September 2nd and 3rd, 2021, to…
blog
2021 Advancing Regulatory Science at FDA: What are the focus areas
The Food and Drug Administration (FDA) conducts research in regulatory science to improve regulatory decision-making by developing new tools and approaches to…
