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Developing Treatments for Rare Diseases – Reviewing Recent FDA Draft Guidances

Developing Treatments for Rare Diseases – Reviewing Recent FDA Draft Guidances

by Avery Zimmerman | Jun 13, 2019 | Blog

New and updated regulatory guidances from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other global health authorities are continually being release. These guidances are...
Behind-the-Scenes: Staying in Front of Pharmaceutical Industry Regulations

Behind-the-Scenes: Staying in Front of Pharmaceutical Industry Regulations

by Avery Zimmerman | Oct 4, 2018 | Blog

Regulations in the pharmaceutical and biotech industry are constantly evolving. Staying informed of all updates and navigating changes internally is a monumental task. To learn how MMS experts traverse these waters, we connect with Amanda Beaster, Ph.D., Technical...
Ask the expert: Policy 0070 redaction packages suspended by EMA until 2019

Ask the expert: Policy 0070 redaction packages suspended by EMA until 2019

by Avery Zimmerman | Aug 2, 2018 | Blog

Last week, the European Medicines Agency announced that as of August 2018, it would “temporarily scale back or suspend additional activities until at least September 2019.” This means that redaction proposal packages submitted until the end of July 2018 will continue...

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