The FDA Regulatory Sciences and Entrepreneurship Program is a dynamic curricular initiative that bridges academia, industry, and regulatory agencies. Led by distinguished faculty, this ...

WASHINGTON (TNND) — 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 10-12 months to ...

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 ...

The U.S. Food and Drug Administration will award up to $50 million over five years to the University of North Carolina at Chapel Hill and Duke University to establish the Research Triangle Center of ...

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 ...

Pharmaceutical companies are growing increasingly concerned widespread cuts at the Food and Drug Administration could set the agency back as crucial review deadlines loom. Why it matters: Health ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

(CNN) — In 1937, a drugmaker called S.E. Massengill Co. came up with what seemed like an improvement on an effective medicine for sore throats: a liquid formulation that tasted like raspberry. The ...

The Food and Drug Administration (FDA) is launching a new program to ramp up the United States’s domestic pharmaceutical supply chain, the agency announced Thursday. The program, called FDA PreCheck, ...

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...

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 ...