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FDA 'Orphan' Status for Pulmonary Fibrosis Drug

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FDA grants Stromedix an orphan drug designation for STX-100, indicated for treating idiopathic pulmonary fibrosis.

FDA Denies Petition on Testing of Emergency Products

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FDA denies a citizen petition asking it to develop testing methods for products to be used by lay individuals in emergency situati...

Online Report Errs: No FDA Implication in AER High Court Case

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A recent online news report about a pending Supreme Court case wrongly suggests the high court is reviewing FDA adverse event repo...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Alphatec Spine, Baxter Healthcare, BioVeda, Diasol, Laboratorios, Patrick Nemech...

Comments Sought on DTC Ad Brief Summary

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Federal Register Notice: FDA seeks comments on a study that is testing different ways of presenting benefit and risk information i...

Review Period Set for Pristiq

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Federal Register Notice: FDA determines the regulatory review period for Pfizers Pristiq for the purpose of patent extension.

Guidance on Penalties for Tobacco Retailers

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Federal Register Notice: FDA releases a draft guidance on civil money penalties for tobacco retailers for violators of the FDA&C A...

Repeat Aralast Ad Violations Raised

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CBER warns Baxter Healthcare of continuing promotional materials violations for its Aralast NP.

FDA Wants Advice on Dextromethorphan Abuse Potential

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FDA asks the Drug Safety and Risk Management Advisory Committee for advice on ways to curb increasing dextromethorphan abuse.

FDA Launches FDA-Track Performance Measure

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FDA launches FDA-TRACK, a performance monitoring and measurement system that it says will be available to the public.