Safety Announcement [11-25-2013]  The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do […]

In an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only, the U.S. […]

en Español [3-14-2013] The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk […]

Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Additional Background Information Safety Announcement [12-22-2011] The U.S. Food and Drug Administration (FDA) is informing the […]

Contains Nonbinding Recommendations Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file?  Assuming each […]

On This Page Date: October 11, 2023 Time: 8:50 AM – 2:50 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

En Inglés Biosimilares: lo que los pacientes deben saber Un biosimilar y su producto biológico original están fabricados con los mismos tipos de fuentes y los […]

On This Page Date: September 6, 2023 Time: 1:00 PM – 3:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT During […]

Docket Number: FDA-2016-D-3561 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Biologics Evaluation and Research […]