An FDA safety alert asks patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-i...
FDA releases its latest batch of Warning Letters that includes one medical product company LifeHealth Science.
FDA Review posts product approval summaries for the week ending 5/29/2020.
An FDA letter reminds healthcare staff to use the correct decontamination cycle associated with certain models of Advanced Sterilization Products Ster...
FDA solicits information from a wide variety of sources on improving the design, conduct, and completion of rare disease clinical trials.
CDER encourages industry sponsors to incorporate the Centers naloxone model drug facts label in development plans for over-the-counter approval of the...
CDER issues its fifth annual drug safety priorities report detailing the effort at multidisciplinary collaboration in the Center.
Federal Register notice: FDA provides notification that it approved a drug product that relied on a priority review voucher for approval Biohaven Pha...