Placeholder Banner

BIO Comments on Prescription Drug-Use-Related Software

April 29, 2019

BIO submitted comments on the Food and Drug Administration’s (FDA) open docket on Prescription Drug-Use-Related Software.

In the comments, BIO says it’s important to encourage innovation and ensure developers are aware of regulatory pathways available for bringing novel technologies to the health care and medical markets. There’s currently insufficient clarity about the regulatory pathway and jurisdiction of drug-use-related software technology.

However, BIO also expresses concern about FDA’s intent to regulate beyond the accepted confines of “labeling,” which has been recognized by the industry and reinforced by the courts. Elements of the framework could stifle innovation. BIO urges FDA to more specifically outline the types of communications it intends to regulate, how review will be coordinated across FDA Centers, and how the framework will interact with other guidance, among other issues.

Download Full Comments Below
BIO Comments Prescription Drug Use Related Software FDA–2018-N-3017
Read full comment letter below
Discover More
February 14, 2020 Re: Docket No. FDA–2020-D-0529: FDA Draft Guidance, Qualification Process for Drug Development Tools Dear Sir/Madam:  The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency)…
February 11, 2020 Re: Docket No. FDA–2019-D-4751: Food and Drug Administration Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs Dear Sir/Madam: The Biotechnology Innovation Organization (BIO…
February 3, 2020 Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding FDA’s public workshop on Patient-Focused Drug Development…