-The proposed regulations permit generic drug companies to initiate CBE changes (overturning the Mensing decision).
-The proposed regulations also require all generics to conform their labeling to an approved CBE change within 30 days. Previously, the regulations only required them to do this as soon as possible.
-Lastly, both brands and generics now may use the CBE process to add new warnings to the “Highlights” section of a new drug labels. This was previously restricted.
Please sign the online petition and share it with your family and friends. This remains extremely important as the rule is still in the proposed phase: https://www.change.org/