Trump is reportedly considering Dr. Stephen Hahn to head the FDA. Others reportedly under consideration include acting Commissioner Ned Sharpless and HHS assistant secretary Brett Giroir.
President Donald Trump must appoint a new commissioner of the FDA by Nov. 1. Ned Sharpless has served as acting commissioner since Scott Gottlieb's departure in March.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
In a letter addressed to Gottlieb, Warren implored him to resign from board of the Big Pharma company, writing "this kind of revolving door influence-peddling smacks of corruption."
The announcement that the former Food and Drug Administration commissioner would join the pharma giant's board had many on social media criticizing what they saw as a revolving door between government and industry.
Gottlieb previously worked at NEA from 2007 to 2017, when he was appointed as commissioner of the FDA. He stepped down from that role in March, also returning to another previous employer, the American Enterprise Institute.
Sharpless pledged to continue the agency's work promoting innovation and competition while tackling problems like vaccine avoidance and marketing of unsafe and unproven health products.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Gottlieb, who announced his resignation last month after 23 months as FDA commissioner, told The Washington Post he would focus on drug pricing and "market failures" that lead to high costs.
The outgoing commissioner requested $55 million to aid the agency's fight against the opioid epidemic.
The guidance concerned strategies for developing precision medicines and more efficient clinical trial oversight. But the outgoing commissioner criticized drugmakers and CROs' reluctance to change their ways.
Sharpless, the director of the National Cancer Institute, was reportedly favored by HHS Secretary Alex Azar as outgoing Commissioner Scott Gottlieb's successor.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Gottlieb, who is expected to step down in about a month, leaves behind a unique legacy and will likely be difficult to replace.
The Washington Post reported Tuesday that Gottlieb, who was appointed FDA commissioner in May 2017, is leaving the agency. In January, he had denied rumors that he would be departing.
The agency plans to release several guidances on complex generics and biosimilars, along with taking a deep dive into the Orange Book patent and exclusivity database.
A range of companies at the Digital Health showcase in San Francisco discussed how they view the changing regulatory environment within the category of software as a medical device.
FDA Commissioner Scott Gottlieb further clarified the pilot program meant to expedite review of digital health technologies and incorporate real world evidence into the regulatory process.