Sunday, February 16, 2020

Sunday, February 16, 2020

Latest News

U.S. FOOD AND DRUG ADMINISTRATION: The Breakthrough Therapy Designation

For two decades, CDER has used certain methods to speed drug development and the regulatory review process so that promising therapies can get to patients faster.

U.S. FOOD AND DRUG ADMINISTRATION: Drug Shortages

Drug shortages have a significant impact on both hospitals and patients.

U.S. FOOD AND DRUG ADMINISTRATION: State of CDER 2019

An audio podcast series featuring the Director of FDA Center for Drug Evaluation and Research

U.S. FOOD AND DRUG ADMINISTRATION: Public Workshop - Forum on Laser-Based Imaging - April 8, 2019

The Forum will focus on the latest trends and enhancements in laser-based imaging modalities such as Optical Coherence Tomography (OCT) and Adaptive Optics (AO), regulatory and reimbursement considerations, and new topics of interest such as the Medical Device Development Tool Program and the emerging role of Artificial Intelligence.

U.S. FOOD AND DRUG ADMINISTRATION: Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices - March 19, 2019

On Tuesday, March 19, 2019, the FDA will host a webinar to share information and answer questions regarding the implementation of the final rule on “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.”

U.S. FOOD AND DRUG ADMINISTRATION: The Least Burdensome Provisions: Concept and Principles Final Guidance - March 14, 2019

On Thursday, March 14, 2019, the FDA will host a webinar on the final guidance entitled, "The Least Burdensome Provisions: Concept and Principles."

U.S. FOOD AND DRUG ADMINISTRATION: FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines

A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality.

FDA Health News