FDA Requests Comments on Generic Drug Submission Criteria
FDA opens public docket on proposed criteria for “first generic” ANDAs.
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 GDUFA website.
Source: FDA.gov
Texas' MD Anderson Cancer Center Creates New Cell Therapy Institute
November 11th 2024With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.
