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Federal Register notice: FDA cancels a 5/15 Advisory Committee meeting due to outstanding review issues related to the safety and ...[ Price : $8.95]
Federal Register notice: FDA modifies the list of standards it recognizes for use in medical device premarket reviews.[ Price : $8.95]
FDA posts Frequently Asked Questions on 3D Printing of Medical Devices, Accessories, Components, and Parts During the Covid-19 Pan...[ Price : $8.95]
Despite repeated urging from president Trump to use the malaria drug chloroquine to treat coronavirus patients, FDA reiterates tha...[ Price : $8.95]
FDA releases the FDA-483 with six observations from a 2017 inspection at Innovative Compounding Pharmacy.[ Price : $8.95]
FDA issues an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive p...[ Price : $8.95]
Teva sues FDA to force it to transition the NDA for Copaxone to a BLA as required under the Biologics Price Competition and Innova...[ Price : $8.95]
FDA accepts an Innocoll Holdings NDA resubmission for post-surgical pain product Xaracoll (bupivacaine hydrochloride collagen-matr...