FDA Focus & Policy Changes - FDA commissioner highlights efforts to rebuild public trust through radical transparency, emphasizing that the government is not your doctor and advocating for individual consultations with healthcare providers [4] - The agency is taking an evidence-based approach to vaccine recommendations, particularly regarding boosters for young, healthy individuals, citing concerns about myocarditis risks and questioning the need for repeated doses without sufficient clinical trials [6][7] - FDA aims to ensure vaccines are available to those who want them, emphasizing the decision is between individuals and their doctors, separate from insurance coverage policies [9][10] - FDA is committed to determining the safety and effectiveness of submitted applications, moving away from rubber-stamping vaccines without clinical trials, especially for young, healthy individuals [12][13] Streamlining Drug Approval & Innovation - FDA is addressing the root causes of health issues, including environmental exposures and chemicals in food, and is inventorying over 1,000 chemicals banned in Europe but present in the US food supply [17] - The agency is working to remove all nine petroleum-based food dyes from the US food supply by next year and is seeking innovation in baby formula, addressing the lack of updates to the FDA recipe in 30 years [18] - FDA is questioning why it takes ten years for a drug to come to market and is implementing programs to reduce animal testing, replace it with computational modeling and organ-on-a-chip technology, and expedite decision-making processes [19][20] - The agency is piloting a priority pathway to potentially reduce decision times to weeks instead of a year and is exploring the use of AI in the review process [20] - FDA is making drug rejection letters public in real-time to increase transparency and predictability for drug developers and investors [21][39] National Priorities & Post-Market Surveillance - FDA is prioritizing large unmet public health needs, domestic manufacturing, and drug affordability as national priorities, aiming to lower drug prices for Americans [23][24][25] - The agency is establishing a post-market surveillance program using big data to monitor drugs immediately after approval, aiming to detect potential issues earlier and potentially change the threshold for approval, especially for rare diseases [26][27] - FDA is interested in seeing cures for type one diabetes, more effective cancer therapies, a universal flu shot, and treatments for neurodegenerative diseases [29][30] FDA Restructuring & Efficiency - FDA has not laid off scientific reviewers or inspectors but has implemented early retirements and is actively hiring scientific reviewers [31][32] - The agency is consolidating redundant services and addressing the "empire building culture" within its centers to improve efficiency and accountability [33][34] - FDA is consolidating its ten different adverse event reporting systems into one to create a better user interface and database for post-market surveillance of drugs [35][36]