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QS Violations Found in Nidek Inspection

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FDAs San Francisco District Office warns Nidek about Quality System and Medical Device Reporting regulation violations in its manu...

Hospira Sues FDA Over Precedex ANDA Carve-out Decision

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Hospira files suit against FDA in Maryland federal court, challenging the agencys 8/18 determination on potential ANDAs for the co...

Grant Funds Available for Orphan Drug Sponsors

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Federal Register Notice: FDA makes available grant funds to support its Office of Orphan Products Development grant program.

CDRH Device Evaluation Chief Foreman Moving to Tobacco Center

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CDRH Office of Device Evaluation director Christy Foreman steps down to accept a new position at FDAs Center for Tobacco Products....

Feds Drop Probe on AstraZeneca PLATO Trial

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The U.S. Department of Justice terminates a 10-month investigation into an AstraZeneca clinical trial called PLATO, which was used...

FDA Mulls Public Process for ANDA 180-day Exclusivity Decisions

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FDA considers whether to make generic drug 180-day exclusivity decisions a public process, including consideration of whether a fi...

Docs Want Distinguishable Biologic Names

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Doctors who regularly prescribe biologics urge FDA to ensure that biosimilars have distinguishable nonproprietary names.

Ecolab Supports Streamlined OTC Review

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Ecolab says FDA needs a streamlined and modernized OTC review process that will support innovation.

FDA Approves Labeling Changes for 73 Products

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FDA approves safety labeling changes for 73 drug products, including Warnings for 28 drugs with a risk for angle-closure glaucoma.

PhRMA Wants False Claims Case Thrown Out

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PhRMA calls on a California federal court to reject arguments from a whistleblower and the government that three drug companies vi...