FDA cleared a Convatec 510(k) for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management.
Federal Register notice: FDA cancels for undisclosed reasons a 3/20 joint meeting of the Nonprescription Drugs Advisory Committee and Anesthetic and A...
FDA clears a Bigfoot Biomedical 510(k) for the Android version of the Bigfoot Unity Mobile App, which is a part of the Bigfoot Unity Diabetes Manageme...
FDA clears a Noah Medical 510(k) for the Galaxy System, a robotic-navigated bronchoscopy device and accessories that are intended to provide bronchosc...
FDA publishes the CDER Drug Safety 2002 Priorities Report reviewing the many drug safety activities the Center undertook in 2022.
CDER director Patrizia Cavazzoni describes how FDA and FTC are working collaboratively to increase competition for biologic products.
The Sedgwick 2022 recall report says both drug and medical device recall events surged higher in 2022, with drugs outpacing devices.
FDA releases the form FDA-483 with eight observations from an inspection at the Madhya, Pradesh, India-based Cipla facility that manufactures sterile ...
