Cures 2.0 Likely To Push US FDA To Further Embrace Real-World Evidence
Draft legislation, which has a good chance of getting wrapped into the next user fee bill, doesn’t give FDA any new authorities or firm mandates on real-world evidence but should nudge agency to more quickly adapt to using RWE for regulatory purposes.
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At his Senate confirmation hearing, Robert Califf said he wants to establish a system, built on electronic medical records, that can be used to more quickly confirm the benefits and risks of accelerated approval drugs.
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.
From next-generation vaccine technology to safety data and global harmonization, what isn’t in the Vaccines and Related Biological Products Advisory Committee preview documents and on the 26 January meeting agenda may be just as important as what is.