HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

Action  The U.S. Food and Drug Administration has approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism. Yorvipath was not studied in adults with […]

What is heartburn? Heartburn occurs when stomach contents flow back up into the esophagus—the muscular tube that carries food and liquids from the mouth to the […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

In 2020, CDER’s Office of Generic Drugs (OGD) and several partner researchers quantified the effect of drug solubility and partition coefficient on the dissolution and subsequent […]

Pharmacometric Models as Tools in Drug Development and Review Pharmacokinetic (PK) models are increasingly relied upon in drug development and review. Typically consisting of a set […]

CDER researchers and collaborators at NCTR are developing pharmacometric models that can support software tools that can be used by clinicians to guide drug dosing for […]

Over the past decade, progress has been made in planning and conducting clinical trials for rare disease drug development. In 2018, for the first time ever, […]

For Immediate Release: August 09, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]