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Breakthrough Devices Updated Final Guidance

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FDA publishes an updated final guidance on the Breakthrough Device program.

De Novo Granted for Esophagus Cooling Device

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FDA grants Attune Medical a de novo marketing authorization for its ensoETM device and its use to reduce the likelihood of ablatio...

FDA Seeks Input on Drug Quality Management Maturity

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Federal Register notice: FDA establishes a docket to solicit stakeholder comments to assist the agency in developing a Quality Man...

Forms FDA 3988 and 3989 Guidance

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FDA publishes a guidance on using forms FDA 3988 and 3989.

AI is FDA Info Technology Plans Top Goal

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FDA says exploring how artificial intelligence can play a role in its regulatory operations is a top strategic goal of its just-re...

FDA 2 Weight Loss Device Guidances

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FDA publishes draft guidances to support clinical and non-clinical testing in premarket submissions for medical devices with a wei...

FTC Warns on Improper Orange Book Patent Listings

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The Federal Trade Commission issues a policy statement, which is supported by FDA, warning brand-name pharmaceutical companies tha...

FDA OKs Updated Temodar Indications

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FDA approves updated and revised labeling for Mercks Temodar under the Oncology Center of Excellence Project Renewal pilot program...

FDA Clarifies Safety of Phenylephrine Products

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FDA issues a safety clarification about its 9/12 Non-prescription Drug Advisory Committees decision that current scientific data d...

Zydus Petition on Indocin Suppositories

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Zydus Pharmaceuticals asks FDA to ensure that Indocin suppositories and their generics meet ICH guidelines and established impurit...