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Wolfe Rips FDA Risk Information Guidance

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Public Citizen health gadfly Sidney Wolfe says a draft FDA guidance on communicating drug risk information tilts too far toward in...

CDER Regulatory Science Research Priorities

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CDER outlines five generic drug regulatory science priorities that will help generic drugs get to market faster.

FDA Wants Extra Study for Acura Hydrocodone Product

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FDA asks Acura Pharmaceuticals for an additional nasal abuse liability study on its Aversion hydrocodone with acetaminophen tablet...

Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effective...

Guidance on Therapeutic Protein Immunogenicity

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Federal Register Notice: FDA releases a guidance: Immunogenicity Assessment for Therapeutic Protein Products.

9 Lots of Aranesp Recalled Due to Particulates

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Amgen recalls nine lots of Aranesp (darbepoetin alfa) 500 mcg prefilled syringes from non-U.S. distributors, wholesalers and a num...

FDA Panel Backs Boehringers Spiriva Respimat

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FDAs Pulmonary-Allergy Drugs Advisory Committee votes to recommend that existing data support approval of Boehringer Ingelheims Sp...

PhRMA Challenges FDAs 4-Tier Biosimilar Hierarchy

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PhRMA asks FDA to eliminate its proposed hierarchical framework for degrees of similarity in using clinical pharmacology data to d...

FDAers Describe Regenerative Medicine Pre-clinical Route

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Three FDAers explain a recent agency guidance document on pre-clinical testing of cell-based regenerative medicine products.

Pew Backing Device Registries

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The Pew Charitable Trusts says barriers should be overcome to make fuller use of medical device registries.