Senators Urge FDA to End Generic Labeling Preemption

Three Senators are urging the FDA to end generic labeling preemption and allow generic-drug makers to make safety changes to product labeling even if it will no longer mirror the brand-drug label. ANDA holders should be able to make these changes using the FDA’s Changes Being Effected process or Prior Approval Supplement process, Sens. Tom Harkin (D-Iowa), Patrick Leahy (D-Vt.) and Al Franken (D-Minn.) said in a Wednesday letter.
Drug Industry Daily