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
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.
