The Food and Drug Administration (FDA) proposed regulations in 2013 to clarify the ability, and the responsibility, of generic drug manufacturers to initiate safety, efficacy, and dosing updates to their products’ labeling. Requiring all prescription drugs to carry up-to-date safety warnings is essential for improving the safety and efficacy of all FDA approved drugs as well as for shoring up needed consumer safeguards and protections. This essential rule will enable generic drug manufacturers to revise drug labeling through the changes-being-effected (CBE-0) process that brand-name manufacturers have used since the 1980s. Extending this process to generic drug manufacturers will give physicians, patients, and their family members access to better and more accurate information about the risks and benefits of the medications they are taking, regardless of whether a drug is brand-name or generic.