The Opportunity And Pitfalls of Seeking Early Scientific Advance In The EU

August 23, 2017

The positives of seeking scientific advice (SA) generally outweigh the negatives. But sponsors need to know what will be required, and the importance of timing, the choice(s) of regulatory bodies, and of high quality briefing documents. Learn more about the benefits of SA as well as several possible drawbacks to avoid.
 

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Closing The Communication Gap Between Developers and the FDA
Closing The Communication Gap Between Developers and the FDA

To get the most out of pre-submission meetings and avoid misunderstandings follow this new framework.

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Bridging The Gap: Satisfying Payers In An Era of Expedited Regulatory Pathways
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Ensure expedited regulatory approval effectively translates into reimbursement and patient access.