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FDA releases its long-awaited Technology Modernization Action Plan that describes short-term actions it is taking to modernize tec...[ Price : $8.95]
CDER issues a MAPP with policies and procedures for product development and pre-submission meetings with potential ANDA applicants...[ Price : $8.95]
FDA finalizes a guidance on drug-related citizen petitions and petitions for stay of action.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for drug/biologic postmarketing studies status ...[ Price : $8.95]
CDRH introduces its STeP safer technologies program.[ Price : $8.95]
FDA grants an orphan drug designation for its novel gene therapy for treating the CEP290 mutation associated retinal disease.[ Price : $8.95]
Federal Register notice: FDA revokes an emergency use authorization issued to Luminex for the xMAP MultiFLEX Zika RNA Assay.[ Price : $8.95]
Attorney Vernessa Pollard says that medical device software pre-certification may lead to greater post-market surveillance and dat...