FDA warns Balance of Nature that it is marketing dietary supplements that the agency considers to be unapproved and misbranded new drugs.
FDA warns South Koreas Won Industry Co. about Quality System and other violations in its manufacturing of the Morning Life Compression Limb Therapy Sy...
FDA issues a draft guidance on developing drugs to treat Sanfilippo syndrome.
Federal Register notice: FDA makes available a draft guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological...
GE Healthcare begins a Class 1 recall of its CareScape Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devi...
In a Politico interview, new FDA commissioner Stephen Hahn stresses the importance of safety in drug importation and dietary supplement regulation.
FDA approves a Conturais PMA for Bulkamid for treating certain patients with stress urinary incontinence.
FDA approves an expanded label for Mercks insomnia drug Belsomra (suvorexant) C-IV to include findings on its use for treating insomnia in Alzheimers ...