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Latest From Cole Werble
Discussion on cutting edge medical technology demonstrates the strong reputation FDA has built as a regulator. Witnesses in the gene editing field said FDA is doing a good job – and Congress is likely to leave it at that.
Big, revolutionary, vertical deals to change structure of health industry are dramatic but tough to pull off. Will CVS PBM customers worry about funding a competitor?
Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.
Pfizer feels that orphan products may present a particularly good area for testing wearable monitors and other digital devices as research tools. The small patient populations and fine distinctions in functional improvement or delay of disease progression may be ideally suited for the digital collection of data.
Web tool to help patients find expanded access program should go live in early June, focusing initially on oncology. That timing should help deflect efforts to enact “Right to Try” legislation.
US agency's April 6 patient-focused drug development meeting on sarcopenia sent two very divergent messages about the status of measuring patient engagement on new drug development: both delivered by an unexpected messenger, former FDAer Ray Lipicky.