“Designing treatments unique to individual patients has always been the promised goal of personalized medicine. After 25 years the FDA has, for the first time, outlined a framework to facilitate these ...
Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been ...
In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...
The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...
After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...
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