21st Century Cures: BIO Comments on FDA Draft Guidance Qualification Process for Drug Development Tools
Re: Docket No. FDA–2020-D-0529: FDA Draft Guidance, Qualification Process for Drug Development Tools
The Biotechnology Innovation Organization (BIO) thanks to the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Qualification Process for Drug Development Tools.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.
BIO commends the Agency for the development of the Draft Guidance on Qualification Process for Drug Development Tools (DDTs) as required by the 21st Century Cures Act. BIO believes that the Draft Guidance provides a useful framework for how new DDTs can be developed and used as well as the process for qualification of such tools, information that will be essential to Sponsors looking to qualify a DDT. BIO has included in this letter several recommendations for FDA’s consideration as the Guidance is finalized including flexibility in timelines, identification of meetings types, detail regarding rescinding or modification of DDTs, alignment of CDRH regulation, use of external experts, and information on prioritization of review.