
Alexander Gaffney
Executive Director, Regulatory Policy and Intelligence at POLITICO
Executive Director, Regulatory Policy & Intelligence @Politico's @AgencyIQ. Tweeting about @US_FDA's regulation of #Pharma, #MedicalDevice, #Biotech & #Health.
Articles
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1 month 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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2 months ago |
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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I wonder how many of the regulatory policy staff at the FDA's Center for Drug Evaluation and Research whose job it was to handle drug shortages and understand complex drug supply chains were laid off last week. Could be relevant to know "very shortly."

Per White House pool: “Were going to be announcing very shortly a major tariff on pharmaceuticals,” Trump said. He said that will bring pharmaceutical production back to the United States.

RT @AP_FDAwriter: Here's what Dr. Peter Marks told me about the decision to block RFK associates from gaining full access to edit vaccine s…

RT @adamcancryn: News: HHS has no plans to rehire 20 percent of the employees it fired earlier this week, despite RFK Jr.'s assertion yeste…