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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 […]
January 29, 2021

Integrated Summary of Effectiveness

This guidance describes the recommended content of the integrated summary of effectiveness (ISE) for inclusion in a new drug application (NDA) or biologics license application (BLA).2 […]
January 29, 2021

Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States – 11/18/2019 – 11/19/2019

On This Page Date: November 18 – 19, 2019 Time: 8:30 AM – 1:00 PM ET Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in […]
January 29, 2021

Weight Loss, Male Enhancement and Other Products Sold Online or in Stores May Be Dangerous

Image Español Whether you’re looking to buy weight loss, male enhancement, or certain other products, these days you’re apt to look for them online, rather than […]
January 28, 2021

2018 First Generic Drug Approvals

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+ 99 210618 Hydroxyprogesterone Caproate Injection USP, 1250 mg/5 mL (250 mg/mL) Multi-dose […]
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