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Cole Werble

Washington, DC
Cole Werble is the former owner and editorial director of FDC Reports, Inc., the publisher of The Pink Sheet, The Gray Sheet, and other leading news publications for the health care industry. He has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector.
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Latest From Cole Werble

Real-World Evidence: Advice, Principles And Examples Emerge From FDA

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.

Review Pathway Clinical Trials

Orphan Drug Development May Be Well-Suited To Digital/Wearables

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.

Rare Diseases Digital Health

Reagan-Udall Expanded Access Navigator Ready To Launch

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.

Clinical Trials Policy

Patient Input Comes Full Circle: Ex-FDAer Gives Feedback To FDA

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.

Regulation Drug Approval Standards

Podcast: What Commissioner Gottlieb Will Mean For The US FDA

Experts from Prevision Policy discuss their initial impressions of Scott Gottlieb as President Trump's choice to lead FDA, his unique policy experience, what it means from the drug industry, 'Council of Elders' drug approvals, and how his selection could impact the user fee negotiations.

FDA Leadership

US FDA's Authority Over CRISPR Is Adequate, NASEM Finds, But Off-Label Challenge May Emerge

National Academies’ report on the fast-advancing genome-editing technologies points out that ways to improve musculature in dystrophy patients will almost certainly raise issues about treatment use in narrow population versus enhancement use in broader population. In most cases, however, specificity of genome-edited products will help limit use of the new therapies to targeted populations.

FDA Policy
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