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October 3, 2022
Published by Med Search on October 3, 2022
Categories
Update [10/3/2022] FDA added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving Evusheld […]
October 3, 2022
Published by Med Search on October 3, 2022
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Docket Number: FDA-2013-N-1434 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Tablets and capsules are widely manufactured and prescribed and may provide a […]
October 3, 2022
Published by Med Search on October 3, 2022
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Introduction FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel efficacy endpoint development for drugs that treat rare diseases. The RDEA […]
October 3, 2022
Published by Med Search on October 3, 2022
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[10/3/2022] FDA is announcing the expansion of the CDER NextGen Portal to enable certain electronic over-the-counter (OTC) monograph submissions to FDA under section 505G of the Federal […]
October 3, 2022
Published by Med Search on October 3, 2022
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FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld Update [10/3/2022] FDA added important information to the authorized Fact […]
October 3, 2022
Published by Med Search on October 3, 2022
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Latest Biosimilar Science and Research News The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health through the rigorous review of applications […]
October 3, 2022
Published by Med Search on October 3, 2022
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Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality […]
October 3, 2022
Published by Med Search on October 3, 2022
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What’s New GDUFA III enhancements for Type II API DMFs start on 10/1/2022 Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed […]
October 3, 2022
Published by Med Search on October 3, 2022
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Q: What is the Rare Disease Endpoint Advancement (RDEA) pilot program? A: The RDEA Pilot Program is a U.S. Food and Drug Administration pilot meeting program, […]
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