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QS, MDR, UDI Issues in Levo AG Inspection

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FDA warns Switzerlands Levo AG about Quality System, Medical Device Reporting, and Unique Device Identifier violations in its prod...

Repeat CGMP Violations at Guangxi Yulin

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A 3/17-3/21 FDA inspection at the Guangxi Yulin Pharmaceutical Group drug manufacturing facility in Yulin, Guangxi, China, found r...

FDA Orphan Status for Netherton Syndrome Drug

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FDA grants Quoin Pharmaceuticals an orphan drug designation for QRX003 and its use in treating Netherton syndrome.

Genentechs Gazyva Approved for Lupus Nephritis

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FDA approves Genentechs Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis who are receiving standard t...

Major Staff Losses at CDER and CBER Amid Shake-up

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FDA releases hiring data showing steep declines in staffing at CDER and CBER.

CGMP Violations Seen in BRS Services Inspection

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FDA warns St. Louis, MO-based BRS Analytical Services about CGMP violations in its production of finished drugs.

GSK and Speros Antibiotic Positive Phase 3 Results

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GSK and Spero Therapeutics report positive Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated u...

FDA Strengthens Tranexamic Acid Warning

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FDA says it is strengthening labeling for tranexamic acid injection products to clarify that it is only to be administered intrave...

FDA Contracts with ISMP on Medication Errors

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FDA contracts with the Institute for Safe Medication Practices for services to strengthen its ability to identify and reduce the r...

Workshop on Patch Tests for Allergic Contact Dermatitis

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FDA hosts a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic...