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Fresenius Kabi Recalls Ketorolac Tromethamine

[ Price : $8.95]

Fresenius Kabi recalls 13 lots of ketorolac tromethamine injection, 30 mg/ml, and ketorolac tromethamine injection 60 mg/2 ml due ...

International Labs Recalls Mislabeled Clopidogrel

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International Laboratories recalls one lot of clopidogrel tablets due to a mislabeling.

CDER Revises ANDA Review Internal Policy

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CDER revises a Manual of Policies and Procedures entitled ANDA Amendments and Supplements Reviewed by the Division of Filing Revie...

New Content Added to Clinical Trials Guide

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FDA adds new content to a question-and-answer appendix for its guidance on Conduct of Clinical Trials of Medical Products during C...

Fast Track for Surufatinib in Pancreatic Neuroendocrine Tumors

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FDA grants Hutchison China MediTech two fast track designations for surufatinib for treating both advanced and progressive pancrea...

NIH, FDA Move on International Research Response

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NIH, FDA, CDC and the European Medicines Agency aim to develop an international strategy for a coordinated research response to th...

Seattle Genetics Tukysa OKd for Breast Cancer

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FDA approves a Seattle Genetics NDA for Tukysa (tucatinib) for use in combination with chemotherapy for treating adult patients wi...

Judge Issues Restraining Order Against Covid-19 Product

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A southern Florida federal judge enters an emergency temporary restraining order and a preliminary injunction against Genesis II C...

Covid-19 Threatens Drug Evaluation Process: Researchers

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Harvard Medical School researchers raise concerns about the risks in hastily allowing the use of unproven drugs to treat Covid-19.

Covid-19 Emergency Compounding Guidance

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FDA says it will not act against outsourcing facilities that take certain actions to compound drugs needed for hospitalized Covid-...