FDAAA Post-Marketing Requirements Growing As Commitments Decline
Safety studies imposed under FDA Amendments Act authorities are a growing portion of sponsors’ post-approval study burden, while post-marketing commitments are declining, according to the latest FDA annual report on the status of post-marketing requirements and commitments.
You may also be interested in...
Since releasing its annual guidance agenda in December, FDA has added a number of guidances to its development agenda.
Industry wanted FDA to impose a detailed set of internal requirements on itself before imposing PMRs, but in final guidance on the subject the agency does not do so.