FDA Approves Drug To Reduce Risk Of Preterm Birth In At-Risk Pregnant Women
The U.S. Food and Drug Administration approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth. The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth...

FDA aims to accelerate medical device reviews
Federal health officials are proposing a plan that would speed up the approval of innovative medical devices that have the potential to dramatically improve patients' lives.

PCI Receives FDA 510(k) Clearance For On-Site Oxygen Generators
PCI, a global leader in the design and manufacture of on-site gas separation systems, has received FDA 510(k) clearance to market their oxygen generators (known as deployable oxygen concentrator systems, or DOCS) as medical devices...