The FDA has announced plans to ease the development of genetic and genomic-based tests and introduced guidelines designed to accelerate the submission process for investigational cancer drugs and biological products.
“This cross-center approach to streamlining the process for determining the review requirements for diagnostics used in drug trials is an example of the Oncology Center of Excellence’s ongoing efforts to expedite the availability of safe and effective cancer treatments for patients,” he said.
- FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests. Accessed April 12, 2018. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604462.htm.
- FDA In Brief: FDA advances policy to make co-development of drugs and diagnostics in cancer trials more efficient. Accessed April 12, 2018. www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm604469.htm.
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