Search Results for keywords:"Center for Drug Evaluation and Research"

The Food and Drug Administration (FDA) has announced a decision to deny Vanda Pharmaceuticals a hearing regarding their supplemental new drug application for HETLIOZ, which is intended to treat insomnia by aiding in sleep initiation. The FDA concluded that the application did not provide sufficient evidence to prove the drug's effectiveness and safety for this new use. Previously, on March 4, 2024, the Center for Drug Evaluation and Research (CDER) issued a complete response letter indicating Vanda's application could not be approved as is. After reviewing submissions from both parties, the FDA finalized their decision not to approve the new indication for the drug on February 28, 2025.

The Food and Drug Administration (FDA) has announced a reorganization of its Center for Drug Evaluation and Research (CDER), specifically within the Office of Surveillance and Epidemiology (OSE) and the Office of New Drugs (OND). This reorganization aims to enhance their ability to support the FDA's mission by improving drug safety and management, addressing drug development for rare diseases, opioids, and other critical areas. The changes include creating several new offices and divisions to streamline operations and respond to legislative requirements. This structure was approved by the Secretary of Health and Human Services and is detailed in the FDA's Staff Manual Guide available online.

The Food and Drug Administration (FDA) has reorganized its Center for Drug Evaluation and Research (CDER), specifically within the Office of Medical Policy (OMP), which was approved by the Secretary of Health and Human Services on November 19, 2024. This reorganization aims to improve the FDA's ability to conduct its public health mission by enhancing its capacity to innovate in clinical trials, using tools such as Artificial Intelligence (AI) and Digital Health Technologies (DHTs). The Division of Clinical Trial Quality has been renamed to the Division of Clinical Innovations to support this focus. This restructuring is intended to foster collaboration, attract a diverse workforce, and modernize policy development to guide innovative drug development practices.

The Food and Drug Administration (FDA) has released new guidelines for companies submitting information electronically related to drug and biologic license applications. This guidance helps ensure that data is submitted in a standardized format, which the FDA uses to plan and conduct inspections of research sites, known as Bioresearch Monitoring (BIMO) inspections. The guidance also clarifies which trials need to include certain information, aiming to enhance the FDA's inspection process for safety and efficacy claims in drug applications. Additionally, the guidance addresses previous technical issues and provides updated instructions for submissions under specific FDA regulations.