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Review Period Set for Onglyza

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Federal Register Notice: FDA determines the regulatory review period for Bristol-Myers Squibbs Onglyza for the purpose of patent e...

FDA Giving Priority Review to Illuvien NDA

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FDA accepts for filing and gives priority review status to Alimera Sciences Illuvien NDA.

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Federal Register Notice: FDA releases a draft guidance on civil money penalties for tobacco retailers for violators of the FDA&C A...

Legislators Cautious on Noninferiority Drug Trials

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Members of Congress say a new GAO reports shows that FDA needs to do more to ensure that non-inferiority trials adequately evaluat...

Grant Funds Available to Enhance Animal Feed Analysis

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Federal Register Notice: FDA makes available supplemental grant funds for Food Emergency Response Laboratory Network microbiologic...

Nanotherapeutics Files IND to Remove Radioactive Compounds

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Nanotherapeutics files an IND with FDA for NanoDTPA, an oral capsule indicated to remove radioactive compounds from the body and h...