FDA warns China’s Hangzhou Yiqi Biotechnology Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA publishes frequently asked questions covering eligibility, statement of interest, and selection of participants for the TEMPO digital health pilot project being run with the Center for Medicare and Medicaid Innovation.
FDA warns China’s Hangzhou Yiqi Biotechnology Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA publishes frequently asked questions covering eligibility, statement of interest, and selection of participants for the TEMPO digital health pilot project being run with the Center for Medicare and Medicaid Innovation.
FDA warns China’s Harbin Jixianglong Biotech about CGMP deviations and other violations in its manufacturing of active pharmaceutical ingredients.
A Stanford Law School Center for the Law and Biosciences fellow says policymakers should consider the growth in breakthrough medical devices cleared through the 510(k) pathway when evaluating FDA’s need for more staff and resources directed to device recall oversight.
