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- Newly Added Guidance DocumentsGuidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
- Additions/Deletions for Prescription and OTC Drug Product ListsThe list has been updated through December 2017.
- Orange Book Zip FileOrange Book Data Files (compressed)
- Medication GuidesMedication Guides from A to Z. Guides provide information on proper drug use, safety, and storage. Visit our page for more info.
- FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (HIV).