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FDA issues Lupin a five-item Form 483 after an inspection at the firms Madhya Pradesh, India manufacturing plant cited significant...[ Price : $8.95]
FDA clears a NinePoint Medical 510(k) to market its Intelligent Real-time Image Segmentation software upgrade for its NvisionVLE I...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Policy Regarding Compliance Dates f...[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension for Biosimilars User Fee Program.[ Price : $8.95]
A joint FDA panel meeting votes 17 to 1 that data support the benefit-risk profile of Sages Zulresso (brexanolone) injection for t...[ Price : $8.95]
FDA clears a Shoulder Innovations 510(k) for the InSet Humeral Short Stem System for partial or total shoulder arthroplasty used i...[ Price : $8.95]
FDA issues a safety alert about labels attached to some Pfizer/Mylan EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, which may b...[ Price : $8.95]
FDA Review posts the Federal Register notices for the week ending 11/2/2018.