FDA warns India’s Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a bioequivalence study.
FDA warns Israel’s Naveh Pharma and Atlanta, GA-based Bigdam about selling unapproved new drugs that are adulterated by CGMP violations.
FDA warns India’s Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a bioequivalence study.
FDA warns Israel’s Naveh Pharma and Atlanta, GA-based Bigdam about selling unapproved new drugs that are adulterated by CGMP violations.
An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.
FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need for shorter, safer and more effective regimens.
