
Alexander Gaffney
Executive Director, Regulatory Policy and Intelligence at POLITICO
VP, Regulatory Policy & Intelligence @Politico's @AgencyIQ. Tweeting about @US_FDA's regulation of #Pharma, #MedicalDevice, #Biotech. Signal: AlecGaffney.01
Articles
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2 months ago |
agencyiq.com | Alexander Gaffney |Laura DiAngelo
Life Sciences | By Alexander Gaffney, MS, RAC, Laura DiAngelo, MPH AgencyIQ has identified 17 executive orders, policies, legislative initiatives, and scenarios that have already, or will likely soon, negatively impact FDA’s employment figures.
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Feb 10, 2025 |
agencyiq.com | Alexander Gaffney
President DONALD TRUMP’s administration is advancing a wide array of reforms intended to shrink the federal bureaucracy and otherwise reduce the power and influence of regulatory agencies. In the wake of these actions, significant FDA staff cuts are likely, making it harder for the agency to maintain its current operations – potentially reducing FDA staff capacity for regulatory reviews of new medical products.
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Dec 2, 2024 |
agencyiq.com | Alexander Gaffney |Rachel Coe
ROBERT F. KENNEDY JR. is President-elect DONALD TRUMP’s intended nominee to be Secretary of the Department of Health and Human Services. While Kennedy has pledged not to take anyone’s vaccines away if he is confirmed as head of HHS, Kennedy would have almost unlimited authority to meddle in FDA’s regulatory processes for vaccines. Here, AgencyIQ provides an in-depth look at how Kennedy could make things more challenging for vaccine companies, even without withdrawing approved vaccines.
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Nov 18, 2024 |
agencyiq.com | Alexander Gaffney
Life Sciences | By Alexander Gaffney, MS, RAC Updated Nov 26, 2024 9:31 AM ESTA new effort announced on Nov. 12 by President-elect DONALD TRUMP is intended to make America’s federal bureaucracy leaner and more efficient.
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Nov 6, 2024 |
agencyiq.com | Alexander Gaffney |Laura DiAngelo |Rachel Coe
The election of DONALD TRUMP as the next President of the United States is likely to have major impacts on the FDA and the life sciences industry. In this ongoing series of explanatory analyses, AgencyIQ answers some of the most common questions from our subscribers about what Trump and a newly elected Congress could mean for the FDA and specific areas of regulation. What does Trump’s election mean for the reauthorization of FDA’s user fee programs?
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Even if Covid-19 vaccine manufacturers wind up getting FDA licensure for new strains, it sure sounds like pediatric indications are going to be a longshot based on Makary's viewpoint here. https://t.co/W3ceibqOmi

Speaking on Fox News last night, HHS Secretary Kennedy says that the MAHA Commission's report is expected to be published next week. AgencyIQ has written about the potential impact of this report on FDA regulation: https://t.co/qPGzYdgKwQ https://t.co/WI4I4qSs07

This didn't get a lot of attention on Friday, but it's a big deal. FDA's top drug advertising oversight officials - the leaders of its Office of Prescription Drug Promotion - just left.

Just published a rather significant scoop for readers of AgencyIQ's "FDA Today" newsletter: The top leaders of FDA's drug advertising division, known as OPDP, are stepping down from the agency. Catherine Gray and Mark Askine informed FDA staff yesterday that they are leaving. https://t.co/CrNiOJfwdG