This page is intended to assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the […]

This list contains GDUFA facility payments received by the Agency. The following table explains the terms used in the list: Column Description Fiscal Year The Fiscal Year […]

Docket Number: FDA-2014-D-0092 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking […]

For Immediate Release: March 29, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]

Docket Number: FDA-2016-D-1280 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical specifications document is to assist interested parties in electronically submitting […]

Laws, Regulations, Guidances, and Compliance Letters Some of the links from this page take you to other government web sites. Once you leave this page, click […]

On This Page Date: May 8 – 9, 2024 Day1: Wed, May 8 9:00 AM – 2:30 PM ET Day2: Thu, May 9 9:00 AM – […]

Los biosimilares son como los genéricos en algunos aspectos, en el sentido de que ambos tipos de medicamentos se comparan con un producto de referencia (original) […]

En Español  Biosimilars: what patients need to know A biosimilar and its original biologic are made from the same types of sources – and have the […]