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January 26, 2021

Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older Guidance for Industry

Docket Number: FDA-2018-D-0178 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations to sponsors on the clinical development of drugs […]
January 26, 2021

Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals

Docket Number: FDA-2001-D-0043 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA) is announcing the availability of a […]
January 26, 2021

Certification Process of Designated Medical Gases

Docket Number: FDA-2012-D-1197 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Title XI, Subtitle B of the Food and Drug Administration Safety and […]
January 26, 2021

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

Docket Number: FDA-2013-D-1446 Issued by: Guidance Issuing Office Center for Devices and Radiological Health This guidance document describes studies and information that FDA recommends be used […]
January 26, 2021

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment

Docket Number: FDA-2014-D-0264 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors in the development of drug […]
January 26, 2021

Street Drug Alternatives

Docket Number: FDA-2000-D-0783 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for those persons who are manufacturing, marketing, or […]
January 26, 2021

FDA’s guidance on uniform national policy (Section 585 of the FD&C Act)

Docket Number: FDA-2014-D-1411 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Office of Regulatory Affairs The Food […]
January 25, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere cambios en la etiqueta para advertir acerca del riesgo de daño neurológico potencialmente permanente por el uso de antibióticos con fluoroquinolona inyectados o de uso oral

Anuncio de seguridad El 15 de agosto, 2013, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) requirió que se […]
January 25, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere cambios en la etiqueta para advertir sobre problemas neurológicos graves pero poco frecuentes, tras una inyección epidural de corticosteroides para aliviar el dolor

Haga clic aquí para ver o imprimir una copia de este comunicado sobre la seguridad de los medicamentos – (PDF -51KB) Anuncio de seguridad [4-23-2014] La […]
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