EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update - Major Changes Several major changes are noted in this “Summary of Changes” document, including: Cl ...

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Synchrocast Ep 3: FDA Scrutiny Around ENDS Products

Synchrogenix's Darshan Kulkarni, Vice President, Regulatory Strategy and Policy, and Evan Richardson, Director, Regulatory Services talk about the recent FDA scrutiny around electronic nicotine delivery system (ENDS) products in this episode of Synchrocast. Evan oversees our work preparing regulatory submissions to the Center for Tobacco Products. Listen to learn more about how the FDA is attempti ...

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