Draft guidance on alternatives to animal testing is due within one year
What the document says“Not later than 1 year after the date of enactment of this subsection, the Secretary shall issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards under this section for drugs intended for topical administration.”
The same paragraph directs the Secretary to consider the kinds of nonclinical tests described in paragraphs (1) through (4) of the first subsection (z) of section 505, or any other alternative to animal testing the Secretary finds appropriate.
What the document actually says“Not later than 1 year after the date of enactment of this subsection, the Secretary shall issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards under this section for drugs intended for topical administration.”
Within one year the agency must put out draft advice. The advice covers tests that do not use animals.
Safety is often shown by testing on animals. Other methods now exist. This asks the agency to say how firms may use them.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.