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OrthoGrid Systems PhantomMSK Trauma Cleared

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FDA clears an OrthoGrid Systems 510(k) for its application PhantomMSK Trauma for use in orthopedic surgery.

Advance Notice, Staffing Still Harm Foreign Inspections: GAO

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New Government Accountability Office findings on FDAs foreign inspection program acknowledge improvements pointing up persistent r...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes OHM Pharma and Teligent Pharma.

Alert on Recalled Products from Basic Reset/Biogenyx

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FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx, have bee...

Waxman-Hatch at Risk: Analysis

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Attorney Kurt Karst says Congress is considering drug pricing legislation that is opposed by the Association for Accessible Medici...

BIO Blasts USMCA Provision

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BIO president Jim Greenwood says the administration and House Democrats have surrendered a powerful tool to protect American biote...

Senators Want Action on Hearing Aid Regs

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Sens. Grassley and Warren ask FDA when draft OTC hearing aid regulations will be published

Verax Asks FDA Not to Take Arbitrary Action

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Verax Biomedical calls on FDA not to take actions that would be considered arbitrary and capricious if unsupported by additional s...

Regenerative Therapies Outcome Measures Needed: Report

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The Alliance for Cell Therapy Now calls on FDA and other agencies to act to measure outcomes related to regenerative cell therapie...

Impurity Concerns Spread to Metformin Generics

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FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and r...