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
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
