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Panel to Discuss Gene Therapy Guidance

[ Price : $8.95]

Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/6 to discuss a guidance on virus...

FDA Corrects Device Reg Errors

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Federal Register Final rule: FDA amends the medical device regulations to correct minor errors.

CDER Policy on Setting Review Goal Dates for Labeling Discussions

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A new CDER policy document outlines procedures for informing NDA/BLA applicants about planned review timelines, including goal dat...

Alkermes NDA for Aripiprazole Lauroxil In Schizophrenia

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Alkermes files an NDA for aripiprazole lauroxil, a once-monthly, long-acting injectable atypical antipsychotic for treating schizo...

FDA Reinspects Alexion Pharmas API Facility

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FDA reinspects Alexion Pharmaceuticals active pharmaceutical ingredient manufacturing facility in Smithfield, RI and documented th...

FDA Clears CorMatrix Cardiovascular Pacemaker Pouch

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FDA clears a CorMatrix Cardiovascular 510(k) for the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic d...

FDA Wins Injunction Against Georgia Firm

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A federal court grants FDA an injunction against dietary supplement maker BioAnue Laboratories (Rochelle, GA) and its owners, Glor...

Sular Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Sular (nisoldipine) ER tablets were not withdrawn for reasons of safety or effectiven...

Hemoglobin A1c Test into Class 2

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Federal Register Final order: FDA classifies hemoglobin A1c test system into Class 2.

Recommendations for Creating Global Regulatory Coalition: Report

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A new report from the Council on Foreign Relations provides recommendations for FDA and its foreign counterparts as they move forw...