Dr. Robert M. Califf
@DrCaliff_FDA
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Husband, father, grandfather. Doctor with heart(s). Commissioner of Food and Drugs - @US_FDA This account has been archived.
Silver Spring, MD
Joined February 2022
Then we could initiate much less expensive and well-targeted clinical trials to answer unsettled questions.
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We are not there yet, but I hope we will soon enter an era in which the digital information collected as part of routine clinical care and used to navigate everyday life will give us a system that can continuously monitor for health trends and the benefits and risks of.
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We recently joined with 9 federal agencies to outline a unified approach to health data exchange, which could unlock the potential to improve health care and health outcomes using innovative technologies like AI.
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Significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.
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This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money.
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Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products.
Today, FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products.
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I want to stress that this is my personal reflection on the status of COVID vaccines, which constitute one of the most important elements of government policy, particularly as it relates to the FDA and my term as Commissioner. It is not intended to be an exhaustive systematic.
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I wanted to share with you an FDA Voices piece I wrote about COVID-19 vaccines.
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We are fully committed to pulling all the levers available to the FDA to make nutrition information readily accessible as part of our efforts to promote public health.
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Nearly everyone knows or cares for someone with a chronic disease that is due, in part, to the food we eat. It is time we make it easier for consumers to glance, grab and go. Adding front-of-package nutrition labeling to most packaged foods would do that.
Today, we are announcing an important step to provide nutrition information to consumers by proposing to require a front-of-package nutrition label for most packaged foods. This proposal plays a key role in our nutrition priorities, which are part of a government-wide effort in
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With the appropriate safeguards in place, artificial intelligence has transformative potential to advance clinical research and accelerate medical product development to improve patient care.
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The FDA is committed to supporting innovative approaches for the development of medical products by providing an agile, risk-based framework that promotes innovation and ensures the agency’s robust scientific and regulatory standards are met.
Today, we issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality.
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Please join me in thanking Dr. Bumpus for her service, her good humor and her leadership. She has had a real and positive impact on this agency and its ability to protect the health of the American public.
I want to express my gratitude to the 20,000 strong who make up the FDA for the opportunity to serve as their Principal Deputy Commissioner. Being a civil servant, working shoulder-to-shoulder with all of them, has been one of the greatest honors of my life.
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It is vital that we focus on the key drivers to combat chronic disease, like healthy eating. Now, people will be able to look for the "healthy" claim to help them find foundational, nutritious foods for themselves and their families.
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It’s critical for the future of our country that food be a vehicle for wellness. Improving access to nutrition information is an important public health effort the FDA can undertake to help people build healthy eating patterns.
Today, we are announcing a final rule to update the definition of the nutrient content claim “healthy.” This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels.
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At the FDA, having strong data and evidence to support the work we do allows us to conduct more thorough analysis and to more effectively weigh the benefits and risks of the products we evaluate.
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I sense that we’re nearing a “tipping point” in which high quality RWD and RWE will take off, significantly lowering the cost of evidence generation and producing evidence much more relevant to translation into clinical care than the current system.
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This is a critical topic with significant implications not only for the FDA’s regulatory work but also for patients and consumers who expect and deserve that the medical products they use will be safe and effective and that the decisions we make regarding that standard involve.
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Thank you to @DukeMargolis for inviting me to speak to a public workshop this week on “Optimizing the Use of Real-World Evidence (RWE) in Regulatory Decision-Making for Drugs and Biological Products.”.
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