BIO Comments on FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry.
BIO welcomes the draft guidance, which establishes a simple and reliable mechanism for identifying submissions with Real-World Data – a new area of regulatory science and policy at FDA.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.