FDA approves an investigator-initiated IND to begin a Phase 1 trial involving ZioPharm Oncologys CD33-specific CAR-T therapy for relapsed or refractor...
A Health Affairs blog post suggests ways in which FDA commissioner nominee Scott Gottlieb could address three complex challenges facing the agency.
FDA releases its latest batch of Warning Letters that includes Criticare Technologies, Organ Recovery Systems, Sal Pharma and Unetixs Vascular.
Federal Register notice: FDA reopens the comment period regarding issues related to utilizing the product identifier for product tracing and improving...
Federal Register notice: FDA determines that a list of drug products were not withdrawn from sale for reasons of safety or effectiveness to make it ea...
FDA issues an FDA-483 to Dr. Reddys Laboratories with 11 inspection observations for the companys formulation manufacturing plant at Bachupally, Hyder...
FDA warns Indias Sal Pharma about CGMP deviations and misbranding of active pharmaceutical ingredients.
FDA warns Unetixs Vascular about Quality System violations in its manufacturing of vascular diagnostic ultrasound systems.