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December 15, 2022
Published by Med Search on December 15, 2022
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Docket Number: FDA-2008-D-0150 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants in developing labeling for cardiovascular […]
December 15, 2022
Published by Med Search on December 15, 2022
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Docket Number: FDA-2013-D-0710 Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Drug Evaluation and Research Center for Devices and Radiological Health The Food […]
December 15, 2022
Published by Med Search on December 15, 2022
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FDA and European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for […]
December 14, 2022
Published by Med Search on December 14, 2022
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Image CaptionElectronic health records are an important part of post-dispensing medical countermeasure monitoring and assessment Background | FDA Guidance & Regulatory Information | Contact | FDA […]
December 14, 2022
Published by Med Search on December 14, 2022
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Submit Comments by 02/13/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
December 13, 2022
Published by Med Search on December 13, 2022
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eCTD Technical Conformance Guide Documentation and Resources 1.8 Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications 11/04/2022 eCTD Backbone […]
December 13, 2022
Published by Med Search on December 13, 2022
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All FDA-approved biological products (biologics), including biosimilars and interchangeable biosimilars, undergo a rigorous evaluation so that health care providers and patients can be confident of the […]
December 13, 2022
Published by Med Search on December 13, 2022
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Biosimilars approved by the FDA are safe and effective biological medications. The availability of biosimilars can provide patients with more treatment options, increase access to lifesaving […]
December 13, 2022
Published by Med Search on December 13, 2022
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En Español Biosimilars are safe and effective medications for treating many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease […]
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