Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/Inspection | Sada Siva Rao.M, (M.Sc, RAC-Drugs).
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We have initiated a rolling Biologics License Application (BLA) submission to the @FDA to seek approval for our lead candidate as a potential one-time treatment for hereditary angioedema (#HAE). Read the press release here: https://t.co/js8lE5nlb8
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The deafness drug approval is the right example to pull, but the regulatory mechanism behind it matters more than the headline suggests.What made that approval possible, structurally, is the FDA's new Plausible Mechanism Framework, which allows a single well-controlled clinical investigation plus confirmatory evidence to establish substantial effectiveness. For a rare genetic condition with a small patient population, that's the difference between a viable program and one that dies in developmen
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