The agency says it’s open to offering speedy approval pathways for new pain medications that can fight the ongoing opioid ...

The Food and Drug Administration on Thursday shared a strategic plan to completely eliminate the agency’s backlog of orphan drug designation requests. The plan comes a week after FDA Commissioner ...

FDA experts at PDA 2025 urges pharma to adopt holistic quality systems, strengthening 483 responses & post-warning letter remediation for compliance excellence.