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
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a…
October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology…
  On behalf of the scientists and researchers the Biotechnology Innovation Organization (BIO) represents, I am writing to request that you publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning…