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Guidance on Systemic Antibacterial Drugs Data

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Microbiology Data for Systemic Antibacterial Drugs Development, Analysis, and P...

Illinois Sues Insys Therapeutics Over Off-label Marketing

[ Price : $8.95]

Illinois attorney general Lisa Madigan files a lawsuit against Insys Therapeutics for deceptively marketing and selling Subsys, a ...

FDA Fast Track for Mallinckrodt Duchenne Drug

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FDA grants Mallinckrodt a fast track designation for Synacthen Depot (tetracosactide) and its use in treating Duchenne muscular dy...

FDA Orphan Designation for Biotie Therapies Liver Drug

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FDA grants Biotie Therapies an orphan drug designation for its BTT1023 drug candidate for treating primary sclerosing cholangitis,...

FDA Grants Lupin Tentative Approval for Generic Paxil

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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 ...

CDRH Forming PED Team for Pediatric Data Extrapolation

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CDRH says it is creating a new Pediatric Extrapolation for Devices team to evaluate and review device submissions that include dat...

FujiFilm Submits Final PMA Module for Breast Imaging

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FujiFilm Medical Systems files the final PMA module for its digital breast tomosynthesis, an optional software upgrade for the Asp...

BIO Principles for Industry/Patient Advocacy Interactions

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BIO issues guiding principles for interactions between it and its members and patient advocacy organizations.

Power Morcellation Down After FDA Warning: Study

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Researchers say that use of electric power morcellators in hysterectomies declined after FDA warnings in 2014.

FDA Begins Accepting REMS in SPL Format Next Month

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FDA says it will begin accepting Risk Evaluation and Mitigation Strategies documents 9/3 in structured product labeling formats as...