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Down Classify Proposal on Cytomegalovirus DNA Assay Devices

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Federal Register notice: FDA proposes to reclassify Class 3 cytomegalovirus deoxyribonucleic acid quantitative assay devices inten...

FDA Withdraws Approval of 2 Belviq NDAs Due to Safety

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Federal Register notice: FDA withdraws the approval of two Eisai NDAs for weight loss drugs Belviq tablets and Belviq XR extended-...

ChemoCentryx NDA Accepted for Avacopan

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FDA accepts for review a ChemoCentryx NDA for avacopan, an orally-administered selective complement 5a receptor inhibitor for trea...

2 Charged in Insys Fentanyl Kickback Scheme

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Two Florida men are charged as part of an Insys Subsys kickback and bribery scheme.

Supplement Market Not Perfectly Regulated: Tave

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FDA dietary supplements director Steven Tave tells an industry conference about a regulatory gap between what the law requires and...

FDA Priority Review for Niemann-Pick Disease Drug

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FDA accepts for priority review a CytRx NDA for arimoclomol for treating Niemann-Pick disease Type C.

Trumps Dangerous Meddling at FDA and CDC

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A Washington Post opinion piece takes issue with President Trump and his administrations meddling for political purposes in FDA an...

Use Drug Master File for Cannabis Proprietary Info: FDA

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FDA encourages stakeholders who are developing drugs containing cannabis to consider using the drug master file pathway to protect...

AstraZeneca Wins Priority Voucher for Koselugo

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Federal Register notice: FDA issues a priority review voucher to AstraZeneca for an approved rare pediatric disease product Kosel...

Draft Guide on Geriatric Information in Drug Labels

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Federal Register notice: FDA makes available a draft guidance entitled Geriatric Information in Human Prescription Drug and Biolog...