January 23, 2017 – FDA Cuts Federal Register Wait for Certain ANDA Approvals

According to FDAnews Drug Daily Bulletin “FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Previously, the FDA would publish its findings that a drug was removed from the market for reasons other than its safety and effectiveness before it approved any related ANDAs. Sponsors must prove that their proposed generics are the same as the reference listed drugs with respect to the active ingredients, dosage forms, route of administration, strength, labeling, and conditions of use, among other characteristics, the draft guidance explained.” Click here for the full story,

or go to our other breaking news story “January 25, 2017: New ANDA Guidance; New Reference Standard Data Added to Orange Book”, to see the source material contained in the draft guidance for industry entitled Referencing Approved Drug Products in ANDA Submissions (see pages 4 and 5 of the new draft guidance).