Placeholder Banner

BIO Comments on FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics

July 8, 2019

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry.

BIO welcomes the draft guidance, which establishes a simple and reliable mechanism for identifying submissions with Real-World Data – a new area of regulatory science and policy at FDA.

BIO encourages FDA to consider how Real-World Data (RWD) or Real-World Evidence (RWE) could be used to generate publicly available information, like public summaries, for the research community. BIO also comments on document submissions for Investigational New Drugs (INDs), New Drug Applications (NDAs), or Biologics License Applications (BLAs). Finally, BIO’s provides recommendations on how to better promote the collection and utilization of RWD or RWE.

 

Download Full Comments Below
FINAL BIO Letter Submitting Documents Using RWE 7-8-19
Read the full comments 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On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins.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October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.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…