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Read Blog PostFDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough...
Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued…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Draft Guidance June 2022 FDA is announcing the availability of a draft…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