2 min read
FDA Prior Knowledge Guidance: A New Framework for Natural History Evidence
June 22, 2026
What the FDA's prior knowledge guidance means for natural history evidence and shared datasets
On June 2,...
We provide impactful strategies and solutions to meet your outsourcing needs in order to plan and run your next clinical trial, program or regulatory submission project. Our 25 years of experience helping emerging and small to mid-size biotech firms take their products from IND to NDA approval are worth taking a look at. In 2018 alone, our team prepared the regulatory submissions for 12% of the NMEs approved by the FDA. And, many of those programs we supported since the writing of the study protocols and IND.
Whether you have a compound and need to get started on your IND, or need to recruit patients quickly to get your early phase trials running or just need medical writing or biostatistical support for your programs - Veristat can help. We provide our impactul solutions on both a full-service or functional service basis.
Speak with us at the Outsouring in Clinical Trials Southern California conference in San Diego, CA on September 24-25, 2019! And, did you know, if you are a Director, VP or C-Suite member of a biotech, pharmaceutical or medical device firm, you can register for free.
Schedule a meeting by filling out the form on the right. Find out how we can help you advance your next clinical trial or regulatory submission to successful outcomes. Or, read some of our recent insightful perspectives.
2 min read
Jul 2, 2026 Veristat Blog
June 22, 2026
What the FDA's prior knowledge guidance means for natural history evidence and shared datasets
On June 2,...
5 min read
Jul 2, 2026 Veristat Blog
Antibody-drug conjugates — or ADCs — are not new. The concept of a "magic bullet" that delivers a cytotoxic payload...