The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.
Research teams and commercial firms are increasingly using genome editing to address farm animal health and welfare, from viral resistance to physical traits.
In two documents FDA discusses the development of drugs for molecular indications and investigational device exemption requirements for IVDs in drug trials.
The wide-ranging discussion with witnesses from Stanford, Johns Hopkins, and Editas Medicine touched on recent advances in research and questions of safety.
Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.
