FDA outlines its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing that the changes ar...
FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.
FDA seeks information from a variety of regulatory partners that will help it establish and implement a Quantitative Medicine Innovation Network.
FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.
FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketing of the Bidop 3 Doppler.
FDA warns Germanys Thomas Brunner Hygiene about CGMP and other violations in its production of unapproved and misbranded antiperspirants.
Jazz Pharma says it will seek FDA approval to remove Zepzelcas (lurbinectedin) second-line metastatic small cell lung cancer indication based on data...
FDA accepts for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance...
