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FDA Approves Reckitt Benckiser Opiod Dependence Drug

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FDA approves a Reckitt Benckiser Pharmaceuticals NDA for Suboxone (buprenorphine HCl/naloxone HCl dihydrate) sublingual film, indi...

FDA Extends Seizure Drug Review Over REMS

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FDA extends by 90 days its review of a Valeant Pharmaceuticals NDA for Potiga (ezogabine) in order to review a recently requested ...

FDA Bars Chinese Eyeglasses

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FDA cracks down on Chinese eyeglass imports that fail to meet required impact-resistance tests, after finding 38-100% broke comple...

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.

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...

14 Products on Latest FDA Quarterly Safety Signal Report

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An FDA safety signal report for the second quarter shows 14 products for which the agency is investigating potential signals of se...

FDA Sends MedImmune a 2nd 'Rejection' Letter on Motavizumab

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FDA sends MedImmune a second complete response letter on motavizumab, this one asking for an additional clinical trial to support ...