FDA To Examine Radioactive Drugs Research Reg
This article was originally published in The Pink Sheet Daily
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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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 The additional comment period will allow for feedback in the context of a draft guidance on exploratory INDs released in April, FDA says.
Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.