Patient advocates are hoping for change under new director Michelle Tarver, while industry groups look to build on former ...

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical ...

What will a second Donald Trump presidency mean for the regulation of medicines in the U.S.? History isn’t likely to repeat ...

FDA sets new record for novel device green lights in CDRH annual report One option the FDA is looking at is making the home a central hub for healthcare. Tarver and Shuren helped launch an agency ...

Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the ...

An ophthalmologist by training with a Ph.D. in epidemiology, Tarver has worked at the FDA since 2009. She has held multiple leadership positions at CDRH, including deputy director of the Office of ...

Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire departments” within the Food and Drug Administration (FDA) that ...

The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday. The regulator approved Vyalev, also known as ...

Dassault Systèmes (Euronext Paris: FR0014003TT8, DSY.PA) today announced the availability of the world’s first guide for the ...

UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug ...