FDA

FDA commissioner Scott Gottlieb, MD, and director of FDA’s Center for Biologics Evaluation and Research Peter Marks, MD, PhD, have issued the following statement on efforts to promote and foster blood pathogen reduction technologies...

Today, the Food and Drug Administration (FDA) issued a letter to healthcare providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and...

The Food and Drug Administration (FDA) announces it has permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to...

The Food and Drug Administration (FDA) announces it has approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not...

The following is a statement from FDA commissioner Scott Gottlieb, MD, on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs...

The Food and Drug Administration (FDA) announces that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test...