Radioactive Drugs Research Comment Period Reopened By FDA
This article was originally published in The Pink Sheet Daily
The agency will accept comments for 60 days on its regulation of radioactive drugs for certain research uses. The additional comment period will allow for feedback in the context of a draft guidance on exploratory INDs released in April, FDA says.
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The agency believes that industry has not taken full advantage of the flexibility provided in investigational new drug regulations. The draft guidance advises sponsors on how to proceed with early Phase I, short-term "microdosing" studies.
The agency is holding a Nov. 16 public meeting to discuss whether new guidance on the use of radioactive drugs for research purposes should be developed, or if the current reg should be revised.
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