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Docket on Pediatric Product Safety Reviews

[ Price : $8.95]

Federal Register notice: FDA establishes a public docket to collect comments related to the post-marketing pediatric-focused safet...

KVK Tech Recalls Pneumonia Antibiotic

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KVK Tech recalls two lots of atovaquone oral suspension, USP 750 mg/5mL based on customer complaints of unusual grittiness in the ...

FDA Accepts 2 Keytruda sBLAs for Review

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FDA accepts for review two Merck supplemental BLAs for its anti-PD-1 therapy Keytruda (pembrolizumab) one for patients with renal...

Lepu Medical Technology Selling Unapproved Covid Tests: FDA

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FDA warns Chinas Lepu Medical Technology it is marketing unapproved Covid-19 test kits in the U.S.

Intended Use Guidance Disappoints Stakeholders: Analysis

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Attorney Patricia Kaufman says many stakeholders will be disappointed by the approach FDA has taken in its new intended use final ...

Boston Scientific Exalt Bronchoscope Cleared

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FDA clears a Boston Scientific 510(k) for its Exalt Model B Single-Use Bronchoscope, designed for use in bedside procedures within...

OMB Approves 4 Information Collections

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Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budge...

CGMP Violations at BBC Group

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FDA warns Chinas BBC Group about CGMP violations in its production of finished pharmaceuticals, along with unapproved new drug and...

Inspection Finds CGMP Issue at Sanit Technologies

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FDA warns Sanit Technologies about CGMP violations in its production of finished drugs.

Stem Cell Therapy Firm Marketing Unapproved Cellular Products

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FDA cautions Stem Cell Therapy of Las Vegas that it is marketing unapproved cellular products and exosomes.