OGD "Variations" Guidance Will Extend ANDA Collapsibility To All Products
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.
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