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FDA Refuse to File on Merck Cholesterol Combo NDA

[ Price : $8.95]

FDA refuses to file a Merck NDA for a combination drug containing the companys Zetia (ezetimibe) and Pfizers Lipitor (atorvastatin...

FDA Issues Tamiflu Oral Compounding Guidance

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FDA says pharmacies facing shortages of commercial Tamiflu oral suspension may compound enough oral suspension from capsules to be...

Guidance on Tobacco Product Ingredients

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Federal Register Notice: FDA releases a draft guidance on the listing of ingredients in tobacco products.

Workshop on Genetic Toxicology

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Federal Register Notice: FDA plans a public workshop 1/25: ICH S2 Genetic Toxicology Issues.

FDA Clears SQI Diagnostics Rheumatoid Arthritis Test

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FDA clears a SQI Diagnostics 510(k) for the SQiDworks Diagnostics Platform and its multiplexed IgXPLEX rheumatoid arthritis (RA) a...

Problem with Roche HIV-1 Monitor Test

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CBER says Roche Diagnostics has confirmed a problem with the quantitation standard copy number in an HIV-1 monitor test.

No Inventory of Falsodex Injection Remains

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CDER says that AstraZeneca has no remaining inventory of its discontinued Falsodex Injection.

Comments Sought on ANADAs

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Federal Register Notice: FDA seeks comments on paperwork associated with ANADAs submitted to CVM.

FDA Issues Emergency Use OK for Flu Drug

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Federal Register Notice: FDA issues an Emergency Use Authorization for peramivir 200 mg/20 mL (10mg/mL) single use vial for IV adm...

FDA OKs Covidiens Generic Actiq

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FDA approves a Covidien ANDA for a generic copy of Anesta Corp.s Actiq (oral transmucosal fentanyl citrate), indicated for treatin...