Scott Gottlieb
Biographic Data
| ID | 8449565 |
|---|---|
| NAME | Scott Gottlieb |
| GIVEN NAMES | Scott |
| FAMILY NAME | Gottlieb |
| SIGNATURE | GOTTLIEB S |
| AFFILIATIONS | American Enterprise Institute |
| ORCID | 0000-0002-9455-3671 |
| VERIFIED | Yes |
| TOTAL WORKS | 17 |
| TOTAL CITATIONS | 0 |
| WORKS AS AUTHOR | 17 |
| WORKS AS EDITOR | 0 |
| FIRST PUBLICATION YEAR | 2021 |
| LATEST PUBLICATION YEAR | 2026 |
| H-INDEX | 0 |
FDA’s Promising New Framework for Rare Genetic Diseases
This JAMA Forum discusses the opportunities and challenges facing US Food and Drug Administration (FDA) new approval paths for individualized therapies to treat rare genetic diseases
New FDA Policies Could Limit the Full Value of AI in Medicine
This JAMA Forum discusses the ways in which recent changes to US Food and Drug Administration (FDA) policies related to the regulation of artificial intelligence (AI) have added new uncertainties for the use of AI tools in medicine
Securing America’s Pharmaceutical Innovation Edge
This JAMA Forum discusses challenges to the US’s standing as a global leader in biomedical innovation from China, in the context of recent reductions in funding for biomedical research by the federal government
Why a Planned Reorganization of the FDA Creates Major Challenges
This JAMA Forum discusses the potential downsides of reorganization of the US Food and Drug Administration (FDA), including introducing inefficiencies, and provides examples of past restructuring efforts
How AI Will Help Solve Medicine’s Productivity Challenges
This JAMA Forum discusses the potential for artificial intelligence (AI) to improve productivity in medicine and explores the changes needed in regulation and reimbursement to support the effective implementation of medical AI tools
Bolstering FDA Pathways for Reducing Death and Disease from Tobacco
This JAMA Forum discusses the US Food and Drug Administration’s efforts to implement the 2009 Family Smoking Prevention and Tobacco Control Act through approval of products that demonstrate evidence to help smokers quit and to reduce their risk of relapse
Congress Must Update FDA Regulations for Medical AI
This JAMA Forum discusses pending legislation in the US House and Senate and the history of the “firm-based approach” the US Food and Drug Administration (FDA) could use when regulating artificial intelligence (AI) medical devices to augment patient care
Is it Time to Refocus the Role of the CDC
This JAMA Forum discusses the responsibilities of public health agencies that overlap with those of the US Centers for Disease Control and Prevention (CDC) and argues that the role of the CDC could be redirected to better meet the needs of its core mission—infectious disease control
Regulators Face Novel Challenges as Artificial Intelligence Tools Enter Medical Practice
This JAMA Forum discusses artificial intelligence tools and the regulatory challenges for global regulatory bodies, including the US Food and Drug Administration, in creating new policies to ensure the safety and efficacy of these tools for patients
How to Safely Integrate Large Language Models Into Health Care
This JAMA Forum discusses categories of artificial intelligence devices such as clinical decision support tools and large language models that are increasing being used in health care and the improvements needed to ensure the accuracy and rigor of these tools for patient use
Strategies for Regulating Disruptive Medical Technologies
This JAMA Forum discusses 3 regulatory lessons from the US Food and Drug Administration that could be used for regulating new medical devices and technologies, such as those that include artificial intelligence
Bringing Transparency and Rigor to Medicare Drug Pricing
This JAMA Forum discusses implementation of the Medicare drug pricing provision of the Inflation Reduction Act of 2022 and ways the new frameworks can be tweaked to achieve the desired public health goals
Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests
This JAMA Forum discusses long-awaited reforms that could modernize the US Food and Drug Administration’s regulatory processes, promote innovation, and provide US consumers greater assurance that the products they use are safe and reliable
Ensuring a Safe and Reliable Supply of Infant Formula in the US
Evaluating Postmarket Vaccine Safety—Time to Consolidate This Mission at a Single Agency
FDA’s Policy Changes for Covid-19 At-Home Diagnostics—Implications for Addressing Other Infectious Diseases and Future Pandemics
The response to the COVID-19 pandemic in the US has been transformed through new technologies
The Need for a US National Clinical Trial Infrastructure in a Public Health Crisis
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Evaluating Postmarket Vaccine Safety—Time to Consolidate This Mission at a Single Agency
FDA’s Policy Changes for Covid-19 At-Home Diagnostics—Implications for Addressing Other Infectious Diseases and Future Pandemics
The response to the COVID-19 pandemic in the US has been transformed through new technologies
The Need for a US National Clinical Trial Infrastructure in a Public Health Crisis
Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests
This JAMA Forum discusses long-awaited reforms that could modernize the US Food and Drug Administration’s regulatory processes, promote innovation, and provide US consumers greater assurance that the products they use are safe and reliable
Ensuring a Safe and Reliable Supply of Infant Formula in the US
Regulators Face Novel Challenges as Artificial Intelligence Tools Enter Medical Practice
This JAMA Forum discusses artificial intelligence tools and the regulatory challenges for global regulatory bodies, including the US Food and Drug Administration, in creating new policies to ensure the safety and efficacy of these tools for patients
How to Safely Integrate Large Language Models Into Health Care
This JAMA Forum discusses categories of artificial intelligence devices such as clinical decision support tools and large language models that are increasing being used in health care and the improvements needed to ensure the accuracy and rigor of these tools for patient use
Strategies for Regulating Disruptive Medical Technologies
This JAMA Forum discusses 3 regulatory lessons from the US Food and Drug Administration that could be used for regulating new medical devices and technologies, such as those that include artificial intelligence
Bringing Transparency and Rigor to Medicare Drug Pricing
This JAMA Forum discusses implementation of the Medicare drug pricing provision of the Inflation Reduction Act of 2022 and ways the new frameworks can be tweaked to achieve the desired public health goals
Bolstering FDA Pathways for Reducing Death and Disease from Tobacco
This JAMA Forum discusses the US Food and Drug Administration’s efforts to implement the 2009 Family Smoking Prevention and Tobacco Control Act through approval of products that demonstrate evidence to help smokers quit and to reduce their risk of relapse
Congress Must Update FDA Regulations for Medical AI
This JAMA Forum discusses pending legislation in the US House and Senate and the history of the “firm-based approach” the US Food and Drug Administration (FDA) could use when regulating artificial intelligence (AI) medical devices to augment patient care
Is it Time to Refocus the Role of the CDC
This JAMA Forum discusses the responsibilities of public health agencies that overlap with those of the US Centers for Disease Control and Prevention (CDC) and argues that the role of the CDC could be redirected to better meet the needs of its core mission—infectious disease control
New FDA Policies Could Limit the Full Value of AI in Medicine
This JAMA Forum discusses the ways in which recent changes to US Food and Drug Administration (FDA) policies related to the regulation of artificial intelligence (AI) have added new uncertainties for the use of AI tools in medicine
Securing America’s Pharmaceutical Innovation Edge
This JAMA Forum discusses challenges to the US’s standing as a global leader in biomedical innovation from China, in the context of recent reductions in funding for biomedical research by the federal government
Why a Planned Reorganization of the FDA Creates Major Challenges
This JAMA Forum discusses the potential downsides of reorganization of the US Food and Drug Administration (FDA), including introducing inefficiencies, and provides examples of past restructuring efforts
How AI Will Help Solve Medicine’s Productivity Challenges
This JAMA Forum discusses the potential for artificial intelligence (AI) to improve productivity in medicine and explores the changes needed in regulation and reimbursement to support the effective implementation of medical AI tools
FDA’s Promising New Framework for Rare Genetic Diseases
This JAMA Forum discusses the opportunities and challenges facing US Food and Drug Administration (FDA) new approval paths for individualized therapies to treat rare genetic diseases
Medicine (12 works) · Business (11 works) · Political science (11 works) · Food and drug administration (8 works) · Administration (probate law (6 works) · Computer Science (6 works) · Health Systems, Economic Evaluations, Quality of Life (6 works) · Law (6 works) · Law (6 works) · Drug (5 works)