Federal Register notice: FDA announces a Premarket Approval Application Critical to Quality pilot program.
FDA releases its latest batch of Warning Letters that includes Dynavision International and HomeoCare Laboratories.
Oregon Health & Sciences University researchers say many hematologists and oncologists who frequently tweet cite drugs positively from companies with ...
FDA announces a pilot program on Approval Application Critical to Quality which aims to evaluate device design and manufacturing process quality infor...
Galena Biopharma agrees to pay the federal government more than $7.55 million to resolve allegations under the civil False Claims Act that it paid kic...
Janssen Sciences discontinues development of its investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivira...
FDA commissioner Scott Gottlieb says a top priority of his is to modernize how clinical information is collected and analyzed.
Federal Register notice: FDA announces a 10/4 Vaccines and Related Biological Products Advisory Committee meeting.