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Aurobindo Hit with FDA-483 After Inspection

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FDA issues a Form FDA-483 to Aurobindo Pharma, citing three observations after investigators inspected the firms Unit XI, an activ...

Humira Patent Thicket Case Dismissal Affirmed

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The 7th Circuit Court of Appeals affirms a lower court decision dismissing a suit charging that AbbVies filing of 132 additional H...

FDA Seeks Comments on Scheduling Changes for 10 Drugs

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Federal Register notice: FDA seeks comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact ...

Woodcock Outlines IT Transformation at FDA

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Speaking at an Alliance for a Stronger FDA Webcast, FDA principal deputy commissioner Janet Woodcock says FDA is working toward ne...

Former FDAer Joins Sidley

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Former CDER combination product team leader Jay Jariwala joins the Sidley law firm.

Keytruda, Lenvima Flunk uHCC Trial

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Merck and Eisai say the combination of Keytruda and Lenvima failed to meet two primary endpoints in a test of patients with unrese...

Resume User Fee Talks: Disease Interests

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Some 99 health-related advocacy and service groups call on Congress to resume consensus talks on user fee reauthorization legislat...

Pfizer Ditches Cardiomyopathy Drug After Trial Miss

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Pfizer discontinues developing PF-07265803 in patients with symptomatic dilated cardiomyopathy after an interim futility analysis ...

FDA Releases More ANDA Draft Bioequivalence Guides

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that address bioequival...

Charles River Wants Endotoxin Assay Regulation

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Charles River Laboratories petitions FDA to exercise regulatory oversight over both natural and synthetic endotoxin contamination ...