OGD "Variations" Guidance Will Extend ANDA Collapsibility To All Products
Executive Summary
FDA's Office of Generic Drug's upcoming guidance on "variations in a drug product that may be included in a single abbreviated application" will extend application "collapsibility" to all dosage forms, Division of Labeling and Program Support Deputy Director Robert West reported at a Regulatory Affairs Professionals Society conference in Newark, N.J. on April 3.