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FDA Grants Lupin Tentative Approval for Generic Paxil

[ Price : $8.95]

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...

Petition Seeks ECT Device Ban

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FDA gadfly attorney Jonathan Emord files a citizen petition asking that electroconvulsive therapy devices be banned or kept in Cla...

Guidance on Refuse to Receive ANDAs for Lack of Impurity Info

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Federal Register Notice: FDA releases a guidance: Abbreviated New Drug Application Submissions Refuse to Receive for Lack of Just...

Guidance on Food for Animals CGMPs

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Federal Register Notice: FDA releases a draft guidance: Current Good Manufacturing Practice Requirements for Food for Animals.

Guidance on Human Food By-products Used for Animal Food

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Federal Register Notice: FDA releases a draft guidance for industry entitled Human Food By-Products For Use As Animal Food.