On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive […]

Overview of FDALabel DatabaseFDALabel Database AccessPotential UsersWhat is Included in Drug Labeling?Database FeaturesLive Queries  Updates and StatisticsUser GuidesAdditional InformationOther ResourcesReferencesContact InformationDisclaimer FDALabel Version 2.8.2 Provide feedback or request […]

To promote transparency and communication, FDA is sharing a list of disease areas where a letter of intent (LOI) has been submitted and ongoing plans exist […]

Hypoparathyroidism EL-PFDD MeetingHost: HypoPARAthyroidism Association Report pending March 5, 2024 Dry Age-Related Macular Degeneration (Dry AMD) EL-PFDD MeetingHost: Foundation Fighting Blindness Report pending March 1, 2024 […]

Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy The Food and Drug Administration (FDA or Agency) […]

The FDA Compounding Quality Center of Excellence conducts the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as well as dynamics between […]

Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy Center for Biologics Evaluation and Research The Food […]

The PDUFA VII and BsUFA III commitment letters provide an update to the definition of face-to-face formal meetings with industry. This update clarifies that a face-to-face […]

FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer 3/05/2024 Jubbonti and Wyost Denosumab-bbdz […]