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FDA Approves Amgens Repatha for High Cholesterol

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FDA approves an Amgen NDA for Repatha (evolocumab) injection for certain patients who are unable to get their low-density lipoprot...

Does FDA Time its Letter Web Postings to Punish?

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FDA obliquely deflects Congressional suspicions that it has used the timing of regulatory letter Web postings to punish recipient ...

User Fees Not Working as Intended: Gulfo

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Rothman Institute of Innovation and Entrepreneurship executive director Joseph Gulfo lists four substantive changes he wants to se...

FDA Stresses Prescriber Education on Opioid Abuse

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FDA tells a House committee that it believes that mandatory prescriber education is an important element in effectiveness of REMS ...

Elite Biomedical Recalls Alaris Pump Membrane

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Elite Biomedical Solutions recalls its Alaris Medley LVP Frame Membrane that is used with the Alaris Medley 8100 infusion pump, ci...

Multiple Violations in Fujifilm Inspection

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A just-released FDA-483 lists five violations found in an agency inspection at Fujifilm Medical Systems.

Fast Track Given to Symbiomix Antibiotic for Vaginosis

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FDA grants Symbiomix fast track status for SYM-1219, which is a single-dose, oral product candidate for treating bacterial vaginos...

Biaxin XL Were Not Withdrawn For S&E

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Federal Register Notice: FDA determines that AbbVies Biaxin XL tablets were not withdrawn from sale for reasons of safety or effec...

Guidance on Shedding Studies for Virus/Oncolytic Products

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Federal Register Notice: FDA releases a guidance: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy...

C. Difficile Assay into Class 2

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Federal Register Final order: FDA classifies C. difficile toxin gene amplification assay into Class 2.