Food and drug administration blog posts

14 September, 2018

Anti-cancer evaluations with ICH S9 Guideline Q&A: what you need to know

By Robert Turcan

The ICH S9 Guideline Q&A document was recently published in June 2018, designed to clarify some of the most common challenges experienced across industry when implementing ICH S9. Here, we highlight a few key areas selected on the basis of the advice sought by our customers during development of their anticancer pharmaceutical.

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03 August, 2018

Did you know the EMA has simplified the orphan drug designation application process?

By Andrea Sisneros

Every month, Envigo’s pharmaceutical regulatory team keeps track of the key changes, influences and opinions that impact the drug development process around the globe.  This month, the team discuss recent changes to the way in which the European Medicines Agency (EMA) has simplified the submission of applications for orphan drug designation.

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03 August, 2018

Regulatory trends: your list of pharmaceutical regulatory affairs changes

By Andrea Sisneros

Each month, Envigo's pharmaceutical regulatory experts review the changes and influences affecting drug development around the world. Dive into some useful resources to ensure you stay in the know about regulatory affairs.

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