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FDAers Boost Viral Clearance in Continuous Manufacturing

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FDA says CDER researchers have developed a three-step process to promote viral clearance during continuous manufacturing of therap...

Senators Want Info on FDA Relationship with McKinsey in Opioid Crisis

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A bipartisan group of six senators quizzes FDA on the potential conflicts of interest in agency contracts with McKinsey since the ...

CGMP Violation Found in Toyobo Inspection

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FDA warns Japans Toyobo Co. about a CGMP violation in its manufacturing of finished drugs.

Guide on ANDA Bioequivalence Studies

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Federal Register notice: FDA posts a draft guidance entitled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submi...

Industry Seeks Changes to Cancer Trials PROs Guidance

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In comments to FDA, drug companies and industry organizations urge the agency to develop additional and broader guidance on patien...

Alexion Scraps Ultomiris ALS Trial

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Citing a lack of evidence, AstraZenecas Alexion drug unit discontinues its CHAMPION-ALS Phase 3 clinical trial of Ultomiris (ravul...

Cardinal Health Recalls Saline Syringes

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Cardinal Health recalls three models of its Monoject Saline Flush Prefilled Syringes because their plunger may pull air into the s...

FDA Approves Pfizer-BioNTech Vaccine

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FDA approves the first Covid-19 vaccine Pfizer-BioNTechs vaccine that is now under the trade name Comirnaty.

FDA Outlines New Changes to Drug User Fee Program

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FDA posts its Prescription Drug User Fee Act VII commitment letter that describes enhancements to the program that will take place...

Product-specific Guidances for ANDAs

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Federal Register notice: FDA updates its listing of product-specific draft and revised draft guidances that provide recommendation...