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FDA Cites QOL Medical for Misleading Promotion of Sucraid

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FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) ...

FDA Warns Brazilian Drug Maker Over Records Request

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FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed ...

HealthPartners Neuroscience Center BIMO Issues

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FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations ...

3-Year New Clinical Investigation Exclusivity Guidance Explained

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Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.

Senate Committee Postpones FDA Funding Bill Consideration

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Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republ...

FDA Accepts 1st Drug-Induced Liver Injury Tool

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FDA has accepted a Letter of Intent for the first in silico artificial intelligence-driven digital liver model for predicting drug...

FDA Accepts Roche NDA for Breast Cancer Drug

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FDA accepts for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy for patients with early-st...

Cingulate Gets FDA Complete Response Letter on ADHD Drug

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FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-defi...

Early Alert on Abiomed Introducer Kits Due to Serious Injuries

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FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with t...

Repeat Medline CGMP Violations Cited

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FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.