February 1, 2021

Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance discusses how FDA plans to exercise its enforcement discretion after August 14, 2001, […]
January 29, 2021

Coronavirus (COVID-19) Update: January 29, 2021

For Immediate Release: January 29, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
January 29, 2021

Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver

Summary Company Announcement Date: December 02, 2018 FDA Publish Date: March 10, 2020 Product Type: Drugs Generic Drugs Reason for Announcement: Recall Reason Description Sterility Concerns […]
January 29, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: La evaluación de un estudio por parte de la FDA esclarece dos muertes relacionadas con el fármaco inyectable para el tratamiento de la esquizofrenia Zyprexa Relprevv (pamoato de olanzapina)

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) ha finalizado la evaluación del estudio llevado a cabo para determinar la causa de […]
January 29, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)

Este informe actualizado se hace en seguimiento al Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso de Revlimid (lenalidomida) […]
January 29, 2021

Patent Certifications and Suitability Petitions

FDA aspires to continually improve its pre-ANDA (abbreviated new drug application) interactions with applicants. To facilitate these interactions and keep stakeholders as informed as possible, the […]
January 29, 2021

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord […]
January 29, 2021

Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps

FDA is undertaking a review of active ingredients used in a variety of over-the-counter (OTC) antiseptic rubs and wash products. Health care antiseptics are being evaluated […]
January 29, 2021

Integration of Dose-Counting Mechanisms into MDI Drug Products

This guidance is intended to assist manufacturers who are developing or plan to develop drug products for oral inhalation using metered-dose inhalers (MDIs). The guidance reflects […]
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