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Court Says Eye Drop Dispenser Suit Preempted

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Attorney JP Ellison says a Massachusetts federal court ruled that suits challenging dispensers for prescription eye drops were pre...

Jonca Bull Leaves FDA Again for PPD Consulting

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FDA Office of Minority Health director Jonca Bull leaves FDA to join Pharmaceutical Product Development in a dual role as head of ...

Drug Compounder Charged with $10 Million Fraud

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The Justice Department announces a plea agreement with an Alabama drug compounder charged with defrauding the Tricare military hea...

FDA/Canada Joint Public Meeting on ICH Preparation

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Federal Register notice: FDA announces a 10/19 regional public meeting entitled Health Canada and U.S. Food and Drug Administratio...

Science Advisory Board Meeting Announced

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Federal Register notice: FDA announces an 11/6-7 Science Advisory Board to the National Center for Toxicological Research meeting.

SCOTUS May Consider FDA Status in Device Suits

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An Alston & Bird client alert says the Supreme Court will decide whether to hear an appeal of a case that asks whether medical dev...

FDA Opens NextGen Collaboration Portal

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CDER opens its Direct NextGen Collaboration Portal through which industry can request pre-ANDA meetings for complex generic drug p...

McGuff NDA for Ascor Approved by FDA

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FDA approves a McGuff Pharmaceuticals NDA for Ascor (ascorbic acid injection USP), a vitamin C drug product for up to one week of ...

FDA Approves Roches Cobas Zika Test

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FDA approves a Roche Molecular Systems PMA for the cobas Zika test, a qualitative nucleic acid test for detectimg Zika virus RNA i...

GDUFA Completeness Assessment Guidance Out

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FDA issues a guidance explaining GDUFA requirements for holders of Type II API DMFs referenced in ANDAs, PSAs, or amendments to ei...