How to Leverage EMA’s ATMP Classification
Advanced therapy medicinal products (ATMPs) have emerged as ground-breaking therapies for rare…
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How to Interpret FDA’s Final Guidance – “Assessing the Effects...
On June 23, 2022, The FDA issued the final version of its…
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Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Final Guidance June 2022 This guidance provides recommendations on an alternate electronic…
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FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough...
Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued…
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EMA Procedural guidance for variant strain(s) update to vaccines intended...
8 June 2022 EMA/175959/2021 Rev.2 Human Medicines Division Regulatory and procedural requirements…
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EMA Checklist for annual updates for parallel distribution – Draft...
22/06/2022 EMA/405782/2020 Rev. 3 Human Medicines Division The European Medicines Agency (hereinafter…
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FDA revises 2013 guidance – Non-Penicillin Beta-Lactam Drugs: A CGMP...
Draft Guidance June 2022 FDA is announcing the availability of a draft…
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Maximising on Scientific Advice Procedures in Europe
A unique opportunity to interact with medicine regulators in Europe Are you…
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