JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
Forbes

FDA Embraces AI To Accelerate Drug Review Process

Forbes contributors publish independent expert analyses and insights. Tor Constantino is an ex-reporter, turned AI consultant & tech writer. In a landmark for U.S. public health digital transformation ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
ascopubs.org

Administrative Aspects of Molecular Diagnostics—Oversight, Regulatory Approval Process, Clinical and Operational Workflows, and Payment Models

Abstract This paper discusses the administrative aspects of molecular diagnostics in oncology, including US Food and Drug Administration (FDA) oversight, the regulatory approval process, clinical, and ...
MedPage Today

FDA Doles Out First Nine Vouchers for Priority Drug Review

The FDA named the first nine products to undergo a new expedited review process that takes 1 to 2 months, the agency announced on Thursday. The nine companies selected to participate in the FDA ...