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Guidance on Residual Solvents in Drugs

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Federal Register Notice: FDA releases a guidance, Residual Solvents in Drug Products Marketed in the U.S.

Residual Solvent Guidance Out

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FDA publishes a guidance to help manufacturers comply with a USP requirement to control residual solvents in drug products.

FDA Warns Medtronic Over Quality System Problems

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FDAs Minneapolis District Office warns Medtronic of Quality System and Medical Device Reporting violations at a cardiac rhythm man...

FDA Clears NanoSphere Assay Updated Labeling

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FDA clears a Nanosphere 510(k) to update its package insert for the Verigene Respiratory Virus Nucleic Acid Test on Verigene SP Sy...

Ad Panel Rejects Excedrin Claim

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A National Advertising Review Board appeals panel recommends that Novartis eliminate or revise a TV spot claim that suggests its E...

FDA Contracts for Pharmaceutical Manufacturing Training

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FDA contracts with the National Institute for Pharmaceutical Technology and Education (NIPTE) for the group to develop a training ...

Plavix Ads Associated with Higher Cost, Not More Use

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Researchers say in the Archives of Internal Medicine that DTC ads for Plavix did not lead to increased use but were associated wit...

Significant Violations Found at Teneo IRB

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A CBER Warning Letter says significant violations of regulations were found in an inspection of the Teneo IRB in Tulsa, OK.

Transcept and FDA Agree to Meet on Rejected Insomnia Drug

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Transcept Pharmaceuticals and FDA agree to meet 1/20/09 to discuss a Complete Response Letter on an NDA for Intermezzo (zolpidem t...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Medtronic, Ocean Hyperbaric Neurologic Center, Teneo IRB, Pressure-Tech, and ZaC...