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Public Citizen Warns Against Routine Tamiflu Use

[ Price : $8.95]

Public Citizen says that some Roche claims for Tamiflu havent been proven and healthy adults should not use the drug for routine f...

Hemispherx Submits Manufacuring Data for Ampligen

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Hemispherx Biopharma and its manufacturing subcontractor submit comprehensive new data to FDAs Seattle, WA regional office to addr...

FDA Adds Boxed Warnings to TNF-Blockers

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FDA releases 11/09 labeling changes for 44 drugs, including boxed warnings for the TNF-blocker class of drugs.

Former Restaurant Association Official Tapped as Hamburg Advisor

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Former National Restaurant Association chief administrative officer Molly Varney Muldoon joins FDA as commissioner Margaret Hambur...

FDA OKs Aurobindo Generic Zyrtec Syrup

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FDA gives final approval to Aurobindo Pharma for cetirizine hydrochloride syrup 1mg/mL, a generic copy of McNeil Consumer Healthca...

Advisors Vote 9-8 for Hexvix

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FDAs Oncologic Drugs Advisory Committee recommends 9-8 that FDA approve Photocures Hexvix bladder cancer imaging drug.

Keryx Biopharmaceuticals Opens a Phase 3 Perifosine Trial

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Keryx Biopharmaceuticals opens a Phase 3 trial of perifosine in relapsed and refractory multiple myeloma patients.

FDA Clears Agendias MammaPrint for All Ages

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FDA clears an Agendia 510(k) for the MammaPrint breast cancer recurrence test that broadens its use to women of all ages.

FDA OKs Elanco sNADA for Swine Feed

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Federal Register Final rule: FDA approves an Elanco Animal Health sNADA for using two-way combination swine feeds formulated with ...

ICH Guidance on Safety of Biotechnology-Derived Pharmaceuticals

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Federal Register Notice: FDA releases an ICH draft guidance, Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-De...