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FDA revises a 3/26 guidance entitled Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.[ Price : $8.95]
Pfizer and BioNTech say that the first participants have been dosed in the U.S. in a Phase 1/2 clinical trial for their BNT162 vac...[ Price : $8.95]
FDA warns Koreas Philosys Co. Ltd. about medical device reporting violations in its manufacturing of blood glucose test systems.[ Price : $8.95]
FDA warns Indias Shriram Institute for Industrial Research about CGMP violations and deviations in its work as a contract testing ...[ Price : $8.95]
Three stakeholders express support for an FDA guidance on including older adults in cancer clinical trials.[ Price : $8.95]
Taiho Oncology says FDA should not permit ANDA applicants for generic forms of its Lonsurf to carve out part of the labeling relat...[ Price : $8.95]
CBER says BioMD is marketing an unapproved human cell, tissue, or cellular or tissue-based product.[ Price : $8.95]
Some 56 advocacy groups representing pro-life and other interests urge FDA to seize Web site domains selling mifepristone and othe...