Commissioner Archives

Abbott baby formula plant in Michigan on track to reopen in 1-2 weeks

Abbott, Commissioner, FDA, Healthcare Companies, Infant Formulas, Therapeutics

Abbott Laboratories and the U.S. Food and Drug Administration are on track to reopen the company’s Sturgis, Michigan, baby formula manufacturing plant within one or two weeks, FDA Commissioner Robert Califf said on May 19.

May 19, 2022/by Reuters Health

FDA approves first Covid-19 test kit for home use

Approvals, Center for Devices and Radiological Health, Commissioner, COVID-19 Infections, COVID-19 self-testing kit, Emergency Use Authorization, FDA, Healthcare Providers, Kits, Moderna, Pfizer, United States

The U.S. Food and Drug Administration approved the first Covid-19 self-testing kit for home use that provides results within 30 minutes.

November 18, 2020/by Reuters Health

How the pandemic changes the health policy outlook

April 2020, Commissioner, Coronavirus Cases, Coronavirus Disease (COVID-19) Pandemic, Department of Health and Human Services (HHS), Donald Trump, Drug Price Legislation, Elections, FDA, FDA/Regulatory, Issue Archives, Jon Bigelow Column, Med Ad News, Senate, United States Department of Homeland Security, White House

This extraordinary March and April – marked by rising numbers of Covid-19 cases and fatalities, suffering for patients and families, courageous efforts by clinicians, restricted social interaction, business closings, massive unemployment – has battered our healthcare system and economy. Here are a few early thoughts on how the evolving pandemic has changed the outlook for health policy after the November elections.

April 27, 2020/by Jon Bigelow

Senate Confirms Stephen Hahn as Next FDA Commissioner

Commissioner, FDA, FDA/Regulatory, Generics, MD Anderson Cancer Center, Oncologists, Senate, U.S. Opioid Crisis, Vaping

The U.S. Senate confirmed Stephen Hahn as commissioner of the U.S. Food and Drug Administration in a 72-18 vote.

December 13, 2019/by BioSpace

Trump nominates MD Anderson oncologist as U.S. FDA Commissioner

Commissioner, Department of Health and Human Services (HHS), FDA, FDA/Regulatory, Oncologists

U.S. President Donald Trump plans to nominate Dr. Stephen Hahn, chief medical executive of the University of Texas MD Anderson Cancer Center, to lead the Food and Drug Administration.

November 1, 2019/by Reuters Health

FDA Acting Commissioner Outlines Regulatory Agency’s Four Top Priorities

21st Century Cures Act, Commissioner, Consumer Safety, FDA, FDA/Regulatory, Health Technology, Patient safety

U.S. FDA Acting Commissioner Ned Sharpless emailed staff outlining the regulatory agency’s four main priorities.

July 24, 2019/by BioSpace

National Cancer Institute chief to serve as acting FDA head

Appointments, Commissioner, FDA, FDA/Regulatory, National Cancer Institute, People on the Move, Shares

U.S. President Donald Trump’s administration tapped National Cancer Institute Director Norman Sharpless to serve as acting commissioner for the Food and Drug Administration.

March 12, 2019/by Reuters Health

U.S. FDA chief steps down abruptly

Analysts, Commissioner, Donald Trump, Drug Prices, E-Cigarettes, Epidemics, FDA, FDA/Regulatory, Generics, People on the Move, Resignations, Stock Markets

FDA Commissioner Scott Gottlieb plans to step down in April 2019, a sudden resignation that calls into question how the regulatory agency will handle issues such as surging e-cigarette use among teens and efforts to increase competition in prescription drugs.

March 5, 2019/by Reuters Health

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

Abbreviated New Drug Applications (ANDAs), Commissioner, Competitive Generic Therapies, Department of Health and Human Services (HHS), Draft Guidance, Drug Competition Action Plan, FDA/Regulatory, Generics

“We have been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development,” says FDA Commissioner Scott Gottlieb, M.D.

February 15, 2019/by Administrator

As Congress struggles with healthcare reform, Gottlieb’s FDA is taking action

Apps, August 2017, Commissioner, Congress, Digital Health, Digital Health Innovation Plan, Drug Competition Action Plan, FDA/Regulatory, Generics, John Kamp, Obamacare/Affordable Care Act (ACA), Opioids, Wall Street, White House

While the nation’s media was focusing on the unsuccessful attempts by Republicans to pass a successor to Obamacare, a fascinating sideshow has developed in nearby White Oak, Maryland, home of the Food and Drug Administration.

August 1, 2017/by John Kamp