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Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.[ Price : $8.95]
FDA accepts for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy c...[ Price : $8.95]
FDA warns Elanco Animal Health that promotional materials for its Zenrelia are misbranded due to false and misleading representati...[ Price : $8.95]
An FDA safety alert says several manufacturers have recalled several lots of immune globulin intravenous and subcutaneous products...[ Price : $8.95]
FDA cautions Indias Chemspec Chemicals about a CGMP deviation in its production of active pharmaceutical ingredients.[ Price : $8.95]
FDA says manufacturers are recalling seven acne products containing benzoyl peroxide to the retail level after testing found possi...[ Price : $8.95]
The Doctor Patient Forum petitions FDA to regulate Bamboo Healths NarxCare platform and other prescription drug monitoring program...[ Price : $8.95]
CDRH chief scientist and deputy Center director Doug Kelly abruptly resigns after less than five years at the agency.