May 18, 2018
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Alerts Health Care Professionals and Oncology Clinical Investigators about an Efficacy Issue Identified in Clinical Trials for Some Patients Taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as Monotherapy to Treat Urothelial Cancer with Low Expression of PD-L1
- FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
- National Drug Code Directory (updated)
- Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry (PDF - 66KB)
- Orange Book
- Orange Book Current Cumulative Supplement 2018 (PDF – 850KB) (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Data Files (compressed) (ZIP - 701KB) (updated)
- Reference Listed Drugs by ANDA Reference Standard List (PDF - 91KB) (updated)
- Orange Book Patent Listing Dispute List (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease Guidance for Industry (PDF - 458KB)
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