Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.
|Articles|November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
Author(s)BioPharm International Editors
FDA opens public docket on proposed criteria for “first generic” ANDAs.
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FDA is requesting comment on proposed criteria for “first generic” abbreviated new drug application (ANDA) submissions. The agency has established criteria for the review prioritization pursuant to the Generic Drug User Fee Amendments of 2012. FDA says these criteria will allow the agency to prioritize and track ANDA submissions, leading to less industry confusion and consistent identification of “first generic” submissions.
FDA has opened a public docket for comments, and more information can be found on the
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