- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present
- Written Requests Issued
- Additions/Deletions for Prescription and OTC Drug Product Lists
- Orange Book Zip File
- Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
- Estudio de seguridad revela el riesgo de coágulos de sangre en los pulmones y muerte con una dosis más alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigará
- La FDA agrega un Recuadro de advertencia por el aumento en el riesgo de muerte con el medicamento para la gota Uloric (febuxostat)
- Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate
- FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
- March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
- February 12, 2019: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee
- Pulmonary-Allergy Drugs Advisory Committee Roster
- FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients
- Comunicado de la FDA sobre la seguridad de los medicamentos La FDA evaluará el riesgo potencial de defectos congénitos del tubo neural ocasionados por el medicamento contra el HIV dolutegravir (Juluca, Tivicay, Triumeq)
- FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
- Non-Inferiority Clinical Trials
- National Drug Code Directory
- La FDA advierte que los síntomas de una afección grave que afecta las células sanguíneas no son reconocidos con el medicamento para la leucemia Idhifa (enasidenib)
- La FDA advierte acerca de los riesgos graves de accidente cerebrovascular y desgarro de las paredes de los vasos sanguíneos con el medicamento para la esclerosis múltiple Lemtrada (alemtuzumab)
- January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
- January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
- FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
- FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
- FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
- December 17-18, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
- Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations
- November 1, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee Meeting Announcement
- Prescription to Over-the-Counter (OTC) Switch List
- October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
- October 10, 2018: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
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