- 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
- Natural Disaster Preparedness and Response (Drugs)
- La FDA advierte acerca de casos poco frecuentes de una infección grave del área genital con los inhibidores del SGLT2 para la diabetes
- FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
- FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
- FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
- Postmarketing Requirements and Commitments: Reports
- Dermatologic and Ophthalmic Drugs Advisory Committee Roster
- La FDA advierte acerca del incremento del riesgo de reincidencia del cáncer con el uso del antibiótico azitromicina (Zithromax, Zmax) a largo plazo posterior a un trasplante de células madre de donante
- FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files
- Pediatric Exclusivity Granted
- FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant
- UPDATED INFORMATION: September 12, 2018: Meeting of the Pharmacy Compounding Advisory Committee Meeting Announcement