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…
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…
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…
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…
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…
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…
Incorporating patients’ voices in the drug development process
Our Senior Director, Mike Day recently interviewed Robyn Bent, Director, CDER PFDD Program, Center for Drug Evaluation and Research, US…
Emergency Response: Getting Ahead of The Competitors
A US based emerging biopharma recognized that one of their anti-viral therapeutics being developed for a different indication might also…