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Regulatory Affairs Blog Posts

June 28, 2022 Regulatory Affairs

How to Leverage EMA’s ATMP Classification

Advanced therapy medicinal products (ATMPs) have emerged as ground-breaking therapies for rare…

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June 27, 2022 Regulatory Affairs

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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June 27, 2022 Regulatory Affairs

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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June 24, 2022 Regulatory Affairs

FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough...

Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued…

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June 24, 2022 Regulatory Affairs

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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June 23, 2022 Regulatory Affairs

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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June 23, 2022 Regulatory Affairs

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Draft Guidance June 2022 FDA is announcing the availability of a draft…

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June 22, 2022 Regulatory Affairs

Maximising on Scientific Advice Procedures in Europe

A unique opportunity to interact with medicine regulators in Europe Are you…

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