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Info Collection on User Fee Program Evaluation

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Federal Register notice: FDA seeks comments on an information collection extension entitled Evaluation of the Program for Enhanced...

Iotech Selling Illegal Covid-19 New Drugs: FDA

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FDA warns Iotech International it is marketing two misbranded, unapproved new Covid-19 drugs in the U.S.

Follow At-Home Covid-19 Test Instructions: FDA

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FDA alerts people to potential injury if at-home Covid-19 tests are not used according to the approved manufacturer instructions.

EUA for Indicaid Covid-19 Rapid Antigen Test

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FDA grants emergency use authorization for an Indicaid rapid at-home over-the-counter Covid-19 antigen test.

FDA Approves Marinus Ztalmy for Rare Epilepsy

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FDA approves Marinus Ztalmy to treat a rare form of epilepsy in patients age 2 and older.

Info Collection Extension on Animal Drug Submissions

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Federal Register notice: FDA seeks comments on an information collection extension for abbreviated new animal drug applications.

Improve Mfg. Deficiencies to Boost ANDA Approval: FDA

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A CDER chart says that avoiding the most common manufacturing deficiencies can improve the quality of ANDA applications and thus t...

5 Issues Facing Califf

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Barrons identifies five issues facing FDA in the next few months that will shed light on how commissioner Robert Califf approaches...

FDA Planning Foreign Inspection Improvement Pilots

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FDA plans several pilot programs to evaluate ways to improve foreign inspections.

FDA Mostly Denies Novartis Zolgensma Petition

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FDA substantively denies a Novartis due diligence petition because the company failed to demonstrate that Regenxbio did not act wi...