FDA issued the final guidance, Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Pathway, that aims to assist sponsors of drug and biological products in developing the Indications and Usage section of product labeling for products approved under the accelerated approval pathway.
The accelerated approval pathway is one of several approaches used by the FDA to expedite the development of drugs for serious or life-threatening diseases and conditions.
The FDA may grant accelerated approval to a product for a serious or life-threatening disease or condition upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.
This guidance focuses on how accelerated approval is represented in the Indications and Usage section of product labeling and offers recommendations to sponsors on language that best conveys different circumstances specific to accelerated approval.
During this period without a FY19 appropriation for the FDA, the agency has been focused on making sure it continues critical aspects of its work, to the extent permitted by law.
At this time, for products covered by a user fee program, our review of existing medical product applications and associated policy development regarding FDA review is funded by limited carryover user fee balances. The FDA will continue to update the public on how it’s approaching the work.
