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Smisson-Cartledges Class 1 Recall of Infusion System IV Sets

[ Price : $8.95]

Smisson-Cartledge Biomedical recalls (Class 1) its ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a cassette...

Cosmo AI Colonoscopy Aid Authorized

[ Price : $8.95]

FDA grants Cosmo Artificial Intelligence a de novo marketing authorization for the GI Genius, the first device that uses artificia...

Comments on Ranking Antimicrobial Use in Animals

[ Price : $8.95]

Federal Register notice: FDA reopens the comment period on an 11/16/2020 public meeting that requested public input on a potential...

Stakeholders Wanted for Generic Animal User Fee Reauthorization

[ Price : $8.95]

Federal Register notice: FDA requests that public stakeholders notify it if they want to participate in periodic consultation meet...

Stakeholders Sought on Animal User Fee Reauthorization

[ Price : $8.95]

Federal Register notice: FDA requests that public stakeholders notify it if they want to participate in periodic consultation meet...

Woodcock Announces Cavazzoni as CDER Head

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FDA acting commissioner Janet Woodcock announces that CDER deputy director for operations Patrizia Cavazzoni has been appointed CD...

Approval Withdrawn for 5 ANDAs

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Federal Register notice: FDA withdraws approval of five ANDAs from multiple holders because they have repeatedly failed to file re...

Meeting on Animal Drug User Fee Act

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Federal Register notice: FDA announces a 5/20 public meeting entitled Animal Drug User Fee Act.

Meeting on Animal Generic Drug User Fee Act

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Federal Register notice: FDA announces a 5/20 public meeting entitled Animal Generic Drug User Fee Act.

FDA Identifies Deficiencies in Provention BLA

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FDA tells Provention Bio that it has identified deficiencies with its BLA for diabetes therapy teplizumab that preclude labeling a...