5 min read
The Tufts CSDD Roundtable took place in November, and on behalf of Veristat, I was honored to participate in this invite-only program. It is part of our company’s DNA to stay ahead of the driving forces in the industry so that we can best serve as a...
2 min read
Did you know approximately 1 in 10 Americans are affected by a rare disease or condition according to the National Institutes of Health (NIH)? That’s 30 million people in the US, and similarly in the EU affected.Before 1983 in the US and 2000 in the EU,...
1 min read
GENESIS BIOMED recently interviewed Xavier Luria, former Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA), and now Veristat’s Vice President of Regulatory Affairs, Europe.
1 min read
The FDA and EMA offer expedited regulatory approval pathways to accelerate time-to-market for novel therapies intended to treat serious conditions and unmet medical needs. There are twelve special designations, many of which reduce clinical development...
4 min read
Effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market.
4 min read
Cell and gene therapies (CGT) are at the frontline of clinical research and offer the potential to transform treatment for serious medical conditions. There are two types of cell therapies in development – autologous and allogeneic. Each provides...
4 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device...
1 min read
Veristat supported a commercial stage biopharmaceutical company in NDA submission, bringing regulatory publishing expertise for a new therapy being developed for the acute treatment of schizophrenia or bipolar disorder-associated agitation. This...
1 min read
There is much for companies to consider before submitting an investigational new drug (IND) application to FDA. Planning, collecting the appropriate data, and effectively communicating with regulatory bodies can all help companies overcome challenges in...
4 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device...