ANDA Complete Response Letters To Become Routine In 2012
Executive Summary
FDA’s Office of Generic Drugs will begin in January 2012 to routinely issue complete response letters for generic drug applications that complete the review process but cannot be approved or tentatively approved.
You may also be interested in...
ANDA Pre-Submission Meetings Being Considered By FDA
Designed to boost application quality, creating such meetings would be another sign of the evolution of the Office of Generic Drugs.
Failed ANDA Bioequivalence Studies Haven’t Impacted Review Decisions, FDA Says
Bioequivalent studies that fail to show bioequivalence between a generic drug and its reference product have not been a factor in ANDA approvals, Barbara Davit, acting director of the Office of Generic Drugs’ Division of Bioequivalence 2, reported at the Generic Pharmaceuticals Association’s fall technical meeting on Oct. 5 in Bethesda, Md.
Failed ANDA Bioequivalence Studies Haven’t Impacted Review Decisions, FDA Says
Bioequivalent studies that fail to show bioequivalence between a generic drug and its reference product have not been a factor in ANDA approvals, Barbara Davit, acting director of the Office of Generic Drugs’ Division of Bioequivalence 2, reported at the Generic Pharmaceuticals Association’s fall technical meeting on Oct. 5 in Bethesda, Md.