Whitepapers

Connecting the Dots: Harnessing Real World Data in Healthcare Decision Making
Drug development is changing, and guidance around the evaluation and approval of new treatments must change with it. The drive to develop medicines for conditions with the most severe unmet need – often rare and with no established or effective standard of care – frequently requires manufacturers to launch technologies based on evidence characterized by non-randomized trial designs with small sample sizes and limited follow-up. Of course, such evidence leads to regulatory and payer decision makers facing a high level of uncertainty when assessing the magnitude of the novel technology’s relative treatment benefit. If we are to accelerate access to transformative therapies, then we must acknowledge that greater flexibility in assessment and payment models is needed to address this uncertainty.
Whitepaper May 13, 2021
How to Apply for an FDA Coronavirus Emergency Use Authorization Letter
Applying for a COVID-19 Emergency Use Authorization (EUA) Letter from FDA is no small feat, even though FDA has tried to simplify the process. We’ve worked directly with FDA on behalf of our clients (as authorized US agents) in order to address deficiencies or revise submissions based on evolving requirements.
Whitepaper May 27, 2020