- Vanda Pharmaceuticals - 576442 - 11/21/2018
- Vanda Pharmaceuticals - 576442 - 10/22/2018
- Nephron SC Inc. - 610867 - 09/22/2020
- Drug Master File (DMF) and Drug Substance Workshop - 03/03/2021 - 03/04/2021
- Coronavirus (COVID-19) Update: March 2, 2021
- Roadmap to 2030 for New Drug Evaluation in Older Adults - 03/23/2021 - 03/23/2021
- FDA Voices on Consumer Safety and Enforcement
- National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
- Health Fraud Scams
- Patient Listening Sessions
- La FDA revisa la etiqueta del medicamento para diabetes canagliflozina (Invokana, Invokamet) para incluir actualizaciones sobre el riesgo de fracturas óseas y nueva información sobre la disminución de la densidad mineral ósea
- KDunn and Associates, P.A. dba HealthQuilt - 611864 - 02/16/2021
- External Resources and Information Related to Patients’ Experience
- GDUFA III Reauthorization Negotiation Sessions
- La FDA refuerza la advertencia de que el estreñimiento no tratado causado por el medicamento para tratar la esquizofrenia clozapina (Clozaril) puede provocar graves problemas intestinales
- Phonetic and Orthographic Computer Analysis (POCA) Program
- Public Meeting on Patient-Focused Drug Development for Vitiligo - 03/08/2021 - 03/08/2021
- Biomarker Qualification Submissions
- La FDA advierte sobre un caso de LMP, una infección cerebral poco común, con el fármaco Tecfidera (dimetilfumarato) para la esclerosis múltiple
- FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma
- FDA Voices on Policy
- FDA Voices
- Coronavirus Treatment Acceleration Program (CTAP) Frequently Asked Questions
- Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
- Rare Disease Day 2021: FDA Shows Sustained Support of Rare Disease Product Development During the Public Health Emergency
- La FDA advierte del riesgo de sufrir daños hepáticos graves con los tratamientos de Viekira Pak y Technivie contra la hepatitis C
- La FDA actualiza las etiquetas de los inhibidores del SGLT2 para la diabetes a fin de incluir advertencias sobre concentraciones de ácido demasiado altas en la sangre e infecciones graves del tracto urinario
- Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
- Over-The-Counter Monograph User Fee Program (OMUFA)
- Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop - 04/09/2021 - 04/09/2021