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Patients, Consumers Want PMA for Shortwave Diathermy Devices

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Patient and consumer groups voice opposition to a request that FDA reclassify shortwave diathermy devices to Class 2.

Cell Structure Study Can Lead to New Medicines

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Brookhaven National Laboratory researchers say their discovery of a molecular sled inside cells may lead to development of new ant...

FDA Chimes in on Comparative Effectiveness Data in Promos

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FDA says comparative effectiveness findings obtained from an observational study cannot be used in advertising or promotional mate...

Multiple Quality Problems Found at IsoAid

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FDAs Florida District Office warns IsoAid about multiple Quality System Regulation violations in its manufacturing of brachytherap...

More FDA Compounding Oversight Sought

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Sen. Richard Blumenthal asks FDA whether it needs greater authority to regulate compounding pharmacies and three other legislators...

Save Money by Extending Drug Expiration Dates: Researchers

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California Poison Control System researchers say expiration dates can be safely extended for many drugs, yielding significant heal...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Akorn, Analyticon Biotechnologies, Bausch & Lomb, First Medical Source, Hospira,...

FDA Posts Zimmer Warning Letter on Validation Issue

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FDA releases a Warning Letter to Zimmer over manufacturing and validation issues cited after an inspection at a manufacturing faci...

FDA Lifts Clinical Hold on Proellex

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FDA reclassifies a full clinical hold on Repros Therapeutics oral Proellex to a partial clinical hold to allow a Phase 2 study eva...

HHS IG is Asked for More Corporate Integrity Guidance

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Companies that have signed a corporate integrity agreement ask the HHS Inspector General for additional guidance on compliance act...