Michael McCaughan

Contributor at Scrip

Founding Member, Prevision Policy LLC Business Implications of FDA and CMS Policy; Policy Implications of Biopharma Business

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Articles

Political Influence And The US FDA: A New Era?

23 hours ago | insights.citeline.com | Michael McCaughan

Political Influence And The US FDA: A New Era? FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting the agency in unprecedented ways about three weeks into his tenure. Politics continues to creep into FDA actions despite Commissioner Martin Makary's declaration that the agency should be apolitical. (Shutterstock)
US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

1 day ago | insights.citeline.com | Michael McCaughan

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals. FDA's Office of Generic Drugs understands the importance of hitting the mark on user fee goal dates. (Shutterstock)
US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

3 days ago | insights.citeline.com | Michael McCaughan

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals. The FDA's Office of Generic Drugs understands the importance of hitting user fee goal dates. (Shutterstock)
US FDA Center Directors Are Political Now

2 weeks ago | insights.citeline.com | Michael McCaughan

US FDA Center Directors Are Political Now The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration. New administrations or FDA commissioners now could expect center directors to leave their posts. (Shutterstock)
US FDA Under Makary: MAHA With A Lighter Touch

1 month ago | insights.citeline.com | Michael McCaughan

US FDA Under Makary: MAHA With A Lighter TouchUS FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency. FDA Commissioner nominee Martin Makary could be confirmed by the Senate in the coming days. (Screenshot of Senate Broadcast)
US FDA Under Makary: MAHA With A Lighter Touch

1 month ago | insights.citeline.com | Michael McCaughan

US FDA Under Makary: MAHA With A Lighter Touch US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency. FDA Commissioner nominee Martin Makary could be confirmed by the Senate in the coming days. (Screenshot of Senate Broadcast)
US FDA Commissioner Nominee Recruiting More Hill Staff Ahead Of User Fee Reauthorization

1 month ago | insights.citeline.com | Michael McCaughan

US FDA Commissioner Nominee Recruiting More Hill Staff Ahead Of User Fee Reauthorization Three Republican congressional staffers will bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere? The three GOP congressional staffers could help the FDA navigate the upcoming user fee reauthorization process. (Shutterstock)
Oz’s Magic: US CMS Administrator Pick Praises Staff, Unlike Other Trump Health Care Nominees

1 month ago | insights.citeline.com | Michael McCaughan

Oz’s Magic: US CMS Administrator Pick Praises Staff, Unlike Other Trump Health Care Nominees US CMS Administrator nominee Mehmet Oz promises to inspire the agency he is set to lead and seems likely to succeed compared to other Trump Administration nominees. CMS Administrator nominee Mehmet Oz appeared to impress Senators from both parties during his confirmation hearing. (Screenshot of CSPAN Broadcast)
Unfreezing US FDA: Generic Drug Officials Make Plea For Public Workshops

1 month ago | insights.citeline.com | Michael McCaughan

Unfreezing US FDA: Generic Drug Officials Make Plea For Public Workshops The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement. OGD wants industry to amplify the perceived value of FDA public meetings. (Shutterstock)
Don’t Ask, Don’t Tell: Senate Democrats Ready To Embrace Makary Heading US FDA

1 month ago | insights.citeline.com | Michael McCaughan

Don’t Ask, Don’t Tell: Senate Democrats Ready To Embrace Makary Heading US FDA US FDA Commissioner nominee Martin Makary appears set for an easy confirmation after Senate Democrats declined to press him on past inflammatory statements about the agency. Democrats did not push Martin Makary on his answers to questions about FDA layoffs. (Shutterstock)