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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

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

Medicaid Reform And Rebates: State “Opt-Out” Proposed At Hearing

Medicaid rebates have been a fact of life in the pharmaceutical industry for 25 years. But the Affordable Care Act repeal-and-replace debate may open up the possibility of eliminating the mandatory rebates – and the requirement that all drugs be covered by the program.

Government Payers Reimbursement

Podcast: US FDA’s ‘Within Label’ Definition Allows Companies To Elaborate On Indications

Permitted speech for approved products could shift dramatically depending on how hard a Trump FDA Commissioner pushes, but the expansion at the end of the Obama Administration is a significant step in its own right – one that former Commissioner Rob Califf emphasizes in an interview that is also available as a podcast.

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