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Endo Pulls Opana sNDA After Meeting with FDA

[ Price : $8.95]

Endo International withdraws its supplemental NDA seeking specific abuse deterrent labeling for Opana ER (oxymorphone HCl extended...

Public Workshop on Neonate Anti-infective Drug Development

[ Price : $8.95]

FDA announces a 9/25 public workshop on Facilitating Anti-infective Drug Development for Neonates and Young Infants to discuss the...

Guidance on Dietary Ingredient Notifications for Supplements

[ Price : $8.95]

Federal Register Notice: FDA issues a revised draft guidance: Dietary Supplements: New Dietary Ingredient Notifications and Relate...

2 Guidances Posted on Electrosurgical Devices

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FDA posts two final guidances on electrosurgical device 510(k) submissions.

BioMerieux Recalls NucliSENS Magnetic Silica

[ Price : $8.95]

BioMerieux recalls its NucliSENS easyMAG Magnetic Silica because of effects on nucleic acids extraction performance.

CTTI Issues Antibiotic Development Recommendations

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The Clinical Trials Transformation Initiative releases new recommendations to streamline antibacterial drug development to treat h...

Lawyer Slams FDA on Foreign Drug Quality Enforcement

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Attorney Mark Schwartz says FDA is finally taking steps to address the fact that it has not had an objective measure of drug quali...

New Dietary Ingredient Notification Guidance Out

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FDA issues a draft guidance on premarket safety notifications for new dietary ingredients.

Actavis Wants Azacitidine AP Rating

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Actavis asks FDA for an AP therapeutic equivalence code for its Azacitidine for Injection.

Advanced Pharma Inspection Report

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FDA releases an FDA-483 with multiple observations from an inspection at Advanced Pharma.