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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…
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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…
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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…
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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…
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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…
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Ask the Experts: How to have an effective INTERACT meeting with the FDA
INTERACT meeting is an informal non-binding consultation with the CBER at FDA. It allows sponsors to obtain preliminary informal consultation…
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What are the reimbursement pathways for innovative digital health technologies?
Innovative digital health solutions are finding their ways into routine patient care in the US and Europe, and different payers…
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Summary of FDA Advisory Committee on COVID-19 Vaccines (Oct 22)
On Oct. 22nd, the Vaccines and Related Biological Products Advisory Committee from FDA held a nine-hour virtual meeting (Advisory Committee Meeting) to…
