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FDA grants Genentech a breakthrough therapy designation for Gazyva (obinutuzumab) for adults with lupus nephritis.[ Price : $8.95]
FDA grants Active Implants a breakthrough device designation for the NUsurface Meniscus Implant.[ Price : $8.95]
FDA clears a Viseon 510(k) for its Voyant System to integrate minimally invasive surgical access with real-time high definition im...[ Price : $8.95]
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.