The U.S. FDA's draft guidance for labeling and patient information for breast implants addresses concerns over anaplastic large cell lymphoma, but the draft also recommends biennial examination via ultrasound or MRI after five years, a recommendation that could prove a boon to makers of these imaging systems.
HONG KONG - China and U.S.-based I-Mab Biopharma Co Ltd. has won two IND clearances for TJ-202/MOR-202 from China's National Medical Products Administration (NMPA).
The FDA's September 2019 final guidance for the humanitarian device exemption program brought some clarity to several issues, but device makers must still untangle the question of which tasks an institutional review board (IRB) has delegated to an appropriate local committee for a specific clinical site.
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