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
PostEra Expands Pfizer Partnership with AI Lab and ADC Collaborations
January 8th 2025The AI Lab was launched almost exactly three years ago and has produced several programs so far, at least one of which achieved its first scientific stage gate 40% faster than the teams originally forecasted.
