FDA cautions healthcare providers that magnetic resonance-guided laser interstitial thermal therapy devices may give inaccurate temperature readings, ...
A new CDER report on developing generic drug transdermal delivery systems examines current and future research opportunities.
A Public Citizen study cautions that clinical trial participants in placebo-only controlled trials of new drugs for life-threatening diseases for whic...
FDA warns Chinas Lijiang Yinghua Biochemical and Pharmaceutical Co. about CGMP deviations in its production of active pharmaceutical ingredients.
FDA warns Mexicos Degasa S.A. De C.V. about CGMP and misbranding violations in its production of finished pharmaceuticals.
FDAs Arthritis Advisory Committee recommends approval of a 2 mg dose of Eli Lillys Olumiant (baricitinib), a once-daily oral drug for the treating mod...
Federal Register notice: FDA makes available a draft guidance entitled Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical De...
CDER describes the 2017 work of its Office of Surveillance and Epidemiology in several drug safety activities.