FDA

Multimedia
August 23, 2023

How AI Could Save Healthcare

By Brian J. Miller | Dan Crenshaw
Press
August 16, 2023

Discussing Supreme Court decision on access to Mifepristone: Yoo on Fox News’ ‘Fox News @ Night’

By John Yoo
Press
July 07, 2023

Discussing the FDA’s New Alzheimer’s Drug Approval: Gottlieb on CNBC’s “Squawk Box”

By Scott Gottlieb
Report
willful ignorance on drug prices
July 06, 2023
Health Affairs

A Priority Review Voucher Program to Fuel Generic Drug Development

By Brian J. Miller | Ted Cho | Patrick Dumas
Article
medical professionals and AI chat bots
June 09, 2023
The JAMA Network

Regulators Face Novel Challenges as Artificial Intelligence Tools Enter Medical Practice

By Scott Gottlieb | Lauren Silvis, JD
Post
May 26, 2023
AEIdeas

Status of Plans to Import Prescription Drugs Purchased at Canadian Prices

By James C. Capretta
Event
October 25, 2023

Preparing for the Federal Legalization of Cannabis

By Brian J. Miller | Stan Veuger | David Joyce | Paul J. Larkin | Sheri L. Orlowitz
Report
March 16, 2023
Social Science Research Network

The 510(K) Third Party Review Program: Promise and Potential

By Brian J. Miller | William Blanks | Brian Yagi
Report
A man tests a vape as Juul brand vaping products are displayed at the Showroom vape shop in Jakarta, Indonesia February 17, 2020. Picture taken February 17, 2020. REUTERS/Willy Kurniawan
March 14, 2023
Social Science Research Network

Appropriate for the Protection of the Public Health: Why We Need Electronic Nicotine Delivery System Product Standards

By Brian J. Miller | Boris Lushniak | Brian Yagi
Article
February 22, 2023
Faster, Please!

In Defense of “Cornucopianism” and a More Populous Planet

By James Pethokoukis
Event
Person getting a shot from a doctor
January 10, 2023

Accurate Race and Ethnic Representation in Pivotal Clinical Drug Trials: Why It Matters and Potential Approaches to Achieve It

By Kirsten Axelsen
Working Paper
December 08, 2022
National Bureau of Economic Research

Regulatory Incentives for Innovation: The FDA’s Breakthrough Therapy Designation

By Amitabh Chandra | Jennifer L. Kao | Kathleen L. Miller | Ariel D. Stern
Op-Ed
December 05, 2022
STAT

Congress Needs to Update FDA’s Ability to Regulate Diagnostic Tests, Cosmetics

By Scott Gottlieb | Mark B. McClellan
Article
Medical-technical assistant Tatjana Miller operates an automatic pipetting machine in a laboratory at the Saxony State Investigation Office (LUA) in Chemnitz to test for pathogens in milk. The goal of the LUA's work in the area of food safety and the safety of consumer goods and cosmetics is to protect consumers from hazards that can arise from unsafe food and materials and objects that are in prolonged contact with the body.
October 13, 2022
The JAMA Network

Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests

By Scott Gottlieb | Mark B. McClellan
Journal Publication
August 04, 2022
British Medical Journal

Response to Acute Monotherapy for Major Depressive Disorder in Randomized, Placebo Controlled Trials Submitted to the US Food and Drug Administration: Individual Participant Data Analysis

By Brian J. Miller
Op-Ed
July 30, 2022
The New York Times

Monkeypox Is About to Become the Next Public Health Failure

By Scott Gottlieb
Post
July 11, 2022
AEIdeas

US E-Cigarette Policy Is Not Harm Reduction, It Is Harm Transfer

By Kirsten Axelsen | Benson Hsu
Press
July 10, 2022

Discussing the suspension of Juul: Gottlieb on Fox News Radio’s ‘Rundown’

By Scott Gottlieb
Op-Ed
June 23, 2022
The JAMA Network

Ensuring a Safe and Reliable Supply of Infant Formula in the US

By Scott Gottlieb
Press
June 23, 2022

Discussing the FDA’s recent regulation of e-cigarettes: Gottlieb on CNBC’s ‘Squawk Box’

By Scott Gottlieb
Op-Ed
Food and Drug Administration Building
February 15, 2022
The Hill

America Needs a Confirmed Leader at FDA — Now

By Scott Gottlieb | Margaret Hamburg | Mark McClellan |
Op-Ed
January 27, 2022
The Wall Street Journal

Should Medicare Decide If You Can Get an Alzheimer’s Drug?

By Scott Gottlieb
Article
December 23, 2021
The JAMA Network

FDA’s Policy Changes for COVID-19 At-home Diagnostics — Implications for Addressing Other Infectious Diseases and Future Pandemics

By Scott Gottlieb
Post
December 21, 2021
AEIdeas

The Alzheimer’s Drug Costs $56K. Should Medicare Cut Next Year’s Premium?

By Joseph Antos