Premier Perspectives

The blog for insider insights in clinical development

Clinical Research: Phase 1 - Phase 4

Using the 505(b)(2) Pathway to Streamline Regulatory Approval for Combination Products

October 26, 2021

Featured Posts

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Medical and Regulatory Affairs

The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One

July 31, 2020

Consulting

UPDATE – Draft FDA Guidance Concerning Combination Products

March 18, 2020

Recent Posts

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Consulting

INTERACT Meetings: Streamlining Early Clinical Development

February 19, 2020