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FDA grants Lupin Ltd. tentative approval for its ANDA for paroxetine extended-release tablets, 12.5 mg, 25mg and 37.5 mg, generic ...[ Price : $8.95]
CDRH says it is creating a new Pediatric Extrapolation for Devices team to evaluate and review device submissions that include dat...[ Price : $8.95]
FujiFilm Medical Systems files the final PMA module for its digital breast tomosynthesis, an optional software upgrade for the Asp...[ Price : $8.95]
BIO issues guiding principles for interactions between it and its members and patient advocacy organizations.[ Price : $8.95]
Researchers say that use of electric power morcellators in hysterectomies declined after FDA warnings in 2014.[ Price : $8.95]
FDA says it will begin accepting Risk Evaluation and Mitigation Strategies documents 9/3 in structured product labeling formats as...[ Price : $8.95]
FDA gadfly attorney Jonathan Emord files a citizen petition asking that electroconvulsive therapy devices be banned or kept in Cla...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Abbreviated New Drug Application Submissions Refuse to Receive for Lack of Just...