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Comment Period Reopened on Sucralfate Guide

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Federal Register notice: FDA reopens the comment period for a revised draft product-specific guidance on sucralfate that appeared ...

Draft Guide on Biopharmaceutics Classification System Biowaivers

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Federal Register notice: FDA makes available a draft guidance entitled Biopharmaceutics Classification System-Based Biowaivers tha...

Shire Seeks Approval for Flexbumin Manufacturing Facility

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Shire files a submission seeking FDA approval for a new plasma manufacturing operation near Covington, GA to manufacture Flexbumin...

Regulatory Review Period Determined for Taltz

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Eli Lillys Taltz (i...

Taiho Oncology sNDA for Lonsurf in Gastric Tumors

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FDA accepts for priority review a Taiho Oncology supplemental NDA for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for...

Mixed Vote on Cardio Risk Trials for Diabetes Drugs

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An FDA Advisory Committee delivers a mixed vote (10 to 9) in favor of continuing required cardiovascular outcomes trials for all n...

Info Collection Extension for REMS Requirements

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Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Product Labeling; Me...

HHS Head Dismisses Industry Resistance to Drug Prices Plan

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Faced with resistance from the pharmaceutical industry, Health and Human Services Secretary and former Eli Lilly executive Alex Az...

Provide Reviews with CRLs: Attorneys

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Three Hyman, Phelps attorneys argue that CDER should change its current process and permit applicants who receive a complete respo...

Biopharmaceutical Classification Biowaivers Guidance

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FDA publishes a draft ICH guidance on biopharmaceutics classification system-based biowaivers.