FDA Releases Draft on Accelerated Approvals for Drugs, Biologics

The drug and biologics industry is getting new guidance on the FDA’s accelerated approval process, a pathway that allows the agency to expedite its review of certain medicines treating serious or life-threatening conditions.

The Food and Drug Administration released a draft guidance Thursday discussing what products may be candidates for accelerated approval, the agency’s standards for granting approval, and the procedures for withdrawing accelerated approval.

Discussion of endpoints, evidentiary criteria, and confirmatory trials are also addressed in the draft guidance.

“The accelerated approval pathway, in appropriate cases, provides for the approval of drugs for serious conditions that fill an unmet ...