FDA warns Indias Shriram Institute for Industrial Research about CGMP violations and deviations in its work as a contract testing laboratory.
Three stakeholders express support for an FDA guidance on including older adults in cancer clinical trials.
Taiho Oncology says FDA should not permit ANDA applicants for generic forms of its Lonsurf to carve out part of the labeling relating to dose reductio...
CBER says BioMD is marketing an unapproved human cell, tissue, or cellular or tissue-based product.
Some 56 advocacy groups representing pro-life and other interests urge FDA to seize Web site domains selling mifepristone and other unapproved abortio...
FDA accepts a Lipocine IND to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioiden...
FDA law book author Roseann Termini joins other voices warning that FDAs Covid-19 battle will be a test of regulated industrys legal preparedness.
Federal Register notice: FDA makes available a final guidance entitled Classification of Posterior Cervical Screw Systems: Small Entity Compliance Gui...