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Regulatory Focus - FDA Names New No. 2 to Replace Retiring Sherman

The US Food and Drug Administration (FDA) announced Monday that Dr. Amy Abernethy will replace Rachel Sherman as Principal Deputy commissioner of Food and Drugs – the highest position at the agency that is not a political appointee.

Bloomberg - Roche Subsidiary Official to Take No. 2 Role at FDA

One of the leading voices in using health data to advance targeted treatments known as precision medicine has been tapped for the second-highest post at the FDA.


Amy Abernethy, chief medical officer for Flatiron Health, will join the Food and Drug Administration as its principal deputy commissioner early next year, FDA Commissioner Scott Gottlieb announced Dec. 17. She will replace Rachel Sherman, a longtime FDA staffer who is retiring in January.


Pink Sheet - HHS Senior Advisor O’Brien Emerges As Azar’s Lead On Drug Pricing In 2019

Executive Summary

O’Brien assumes role from his late colleague and friend Dan Best as HHS closes out administrative items in the blueprint.


The Trump Administration appears to be ramping up towards some kind of action on drug pricing early in the New Year.


Over the last two weeks, HHS Secretary Alex Azar has been posting regular pictures of meetings with a variety of stakeholders on the issue of drug prices.


Pink Sheet - US FDA Taps Abernethy As Principal Deputy Commissioner; Health IT Exec Brings “Real-World” Expertise

Executive Summary

Abernethy comes to FDA from Flatiron Health, which develops oncology-specific electronic health record software and real-world evidence for cancer research. She succeeds FDA veteran Rachel Sherman, who will retire from the agency in January.


Pink Sheet - Has R&D Productivity Rebounded? US FDA Officials Think So

Executive Summary

Record-setting pace of NME approvals is a cause for celebration. But is it a sign that drug industry R&D productivity has actually improved? The US FDA’s top drug review official thinks so – but the data aren’t yet clear.


The US Food & Drug Administration is already in record territory with 55 new molecular entity/novel biologic approvals already in 2018, with almost three weeks still left in the year.


Disability Scoop - Drugs In The Works To Treat Autism’s Core Symptoms

Federal regulators put two experimental drugs targeting autism’s core symptoms on a fast track for testing and approval this year, but they’re still a long way from pharmacy shelves.


Pink Sheet - Four Rules For Being A Consistent US FDA Reviewer From Peter Stein

Executive Summary

Amid concerns Office of New Drugs reorganization will result in sponsors receiving conflicting advice, new director offers several items already contemplated to prevent such problems.


The US FDA's Office of New Drugs wants external stakeholder oversight to accompany standardization and other internal efforts to ensure reviewer consistency after its reorganization.


Journal of Clinical Pathology - NCI Updates Clinical Trial Criteria in Favor of Precision Medicine

The National Cancer Institute (NCI) updated its clinical trial criteria to allow patients with specific health concerns to participate in NCI-funded clinical trials, as well as provide opportunities for patients younger than 18 years to take part in adult cancer trials.


Health IT Analytics - NCI Supports Precision Medicine with Updated Clinical Trial Criteria

The National Cancer Institute (NCI) has revised its clinical trial protocol template to expand eligibility criteria for cancer clinical trials. The updated criteria will allow patients with certain health conditions to participate in NCI-funded trials, as well as provide opportunities for patients younger than 18 to take part in adult clinical trials under certain circumstances.



The National Cancer Institute broadened the criteria for participation in NCI-funded clinical trials after meetings with cancer research organizations and the FDA. The new criteria expands eligibility to include patients with brain metastases, HIV/AIDS, chronic hepatitis B, organ dysfunction and a history of hepatitis C or cancers beyond the trial’s target. It also removes barriers for patients under 18 to enroll in trials, which the FDA has said previously is a priority in promoting trial diversity.