FDA Requests Comments on Generic Drug Submission Criteria

News
Article

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

Recent Videos
Drug Digest: Strategic Partnerships
Michelle Bridenbaker from Unbiased Science discusses her thoughts on the key industry from 2024 and those she anticipates will impact the industry in 2025 and beyond.
Henny Zijlstra from Adragos Pharma chats about the trends affecting the outsourcing market, various strategies being employed by service providers, and the value of end-to-end services.