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Panel to Discuss Cook Pediatric Esophageal Device

[ Price : $8.95]

Federal Register notice: FDA announces a 9/17 Pediatric Advisory Committee to discuss a pediatric-focused safety review of Cook Me...

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Intended Use Guidance Disappoints Stakeholders: Analysis

[ Price : $8.95]

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

[ Price : $8.95]

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

SpinTech MRI Software Cleared by FDA

[ Price : $8.95]

FDA clears a SpinTech 510(k) for its Stage magnetic resonance imaging software.

Metastasis-Free Survival Endpoint Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Conside...

Guide on Near Infrared Analytical Procedures

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Development and Submission of Near Infrared Analytical Proc...