In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance).
On May 31, FDA proposed a change to standardize and consolidate prescription drug product labels into patient guides with essential medication information on safe use.
On May 17, the U.S. Food & Drug Administration ("FDA") issued two important draft guidance documents, which clarify the agency's approach to requirements and incentives in the realm of pediatric drug development.
On April 5, 2023, the U.S. Food and Drug Administration ("FDA") announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection ("Makena".