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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

'Dear Doctor Mom' – US FDA Urged To Find Way To Reach Pediatric Patient Parents With Safety Updates

How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.

Drug Safety Advisory Committees

Patent “March-In” As Price Control Draw Little Support At US National Academies Meeting

The use of patent “march-in” rights as a tool to control the price of drugs developed with US federal funding support remains substantially less popular with the government-funded research community than with politicians.

Pricing Debate Pricing Strategies

US Medicare And Opioids: Inspector General Sees Improvement

HHS is slowly changing its rhetoric on the use of prescription opioids – edging away from crisis to finding positive trends. A new OIG report on opioid use in Medicare Part D emphasizes sustained positive trends in naloxone rescue and medication assisted treatment alternatives to opioid use disorder.

Neurology Medicare

US FDA Compounding Oversight: Not As Bad As FDA Makes It Sound?

HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.

Manufacturing Quality

Benefit-Risk Math: US FDA Still Favors Simple Calculations

A core group of big pharma companies has been pressing FDA for over a decade to adopt a quantitative formula for conducting and communicating benefit-risk decisions. FDA has changed its benefit-risk calculations in response – but not its basic way of doing the math.
Drug Approval Standards Drug Review

US FDA “Enriches” Trial Guidance With Recent Examples

Illustrating that principles articulated in 2012 draft are being broadly accepted at FDA, final guidance on enrichment strategies for clinical trials adds new examples from across the agency’s drug review divisions.
Clinical Trials Drug Approval Standards
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