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October 4, 2022
Published by Med Search on October 4, 2022
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Sign up to receive FDA Recognized Antimicrobial STIC Breakpoints email notifications For information regarding prior changes to the STIC webpages, see https://www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/2019-09007.pdf https://www.federalregister.gov/documents/2020/10/22/2020-23439/21st-century-cures-act-annual-compilation-of-notices-of-updates-from-the-susceptibility-test Updates to Standards […]
October 4, 2022
Published by Med Search on October 4, 2022
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Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Robert T. Flynn Recipient Title Chief Executive Officer Sterling Pharmaceutical Services, LLC 109 S 2nd St.Dupo, […]
October 3, 2022
Published by Med Search on October 3, 2022
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Session Recordings Speakers Keynote: CDER’s Commitment to Pharmaceutical Quality Patrizia Cavazzoni Deputy Center Director for Operations CDER The Importance of Quality in Our Medicines Michael Kopcha […]
October 3, 2022
Published by Med Search on October 3, 2022
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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 […]
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