FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were false or misleading because they overstated the drug's benefits and omitted important risk information.
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were false or misleading because they overstated the drug's benefits and omitted important risk information.
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA warns Mexico’s Laboratorios Jaloma about CGMP violations in its production of finished drugs.
FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.
