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Federal Register notice: FDA makes available a draft guidance entitled Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical De...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.
FDA releases its latest batch of Warning Letters that includes Degasa S.A. De C.V. and Lijiang Yinghua Biochemical and Pharmaceutical Co.
A federal judge sentences three individuals who fraudulently marketed and sold over $16 million worth of light-emitting medical devices as a cure-all ...
FDA posts a draft guidance on Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.