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News Articles: Food and Drug Administration

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022. Lawsuits have been filed in West Virginia and North Carolina challenging the states' restrictions on the use of abortion pills.

Tagged as: 

  • News

New lawsuits target state restrictions on abortion pills

Supporters of abortion rights have filed separate lawsuits challenging abortion pill restrictions in North Carolina and West Virginia. The lawsuits were filed Wednesday.

January 26, 2023
|
By:
  • Associated Press
The Food and Drug Administration announced it has  loosened some restrictions on the pill mifepristone, allowing it to be dispensed by more pharmacies and without an in-person exam.

Tagged as: 

  • Medical Treatments

Abortion pills should be easier to get. That doesn't mean that they will be

Changes by the FDA mean patients won't have to schedule in-person exams to get a prescription. That opens the door for more pharmacies to provide the medication. But not everyone will have access.

January 05, 2023
|
By:
  • Vanessa Romo and
  • Sydney Lupkin
Food and Drug Administration (FDA) signage is seen through a bus stop at the U.S. Department of Health and Human Services, Thursday, Aug. 2, 2018, in Silver Spring, Md., on the FDA grounds.

Tagged as: 

  • Food

Food safety will rely on better traceability data, says new FDA rule

Harvesters, processors, manufacturers and others in the food chain have three years to comply with the new record keeping system, effective next month

December 30, 2022
|
By:
  • Sofi Gratas
The drugmaker Amylyx is asking the FDA to approve a new medication for ALS, a fatal neurodegenerative disease. It's possible the agency could greenlight the drug by the end of the month.

Tagged as: 

  • Health

FDA seems poised to approve a new drug for ALS, but does it work?

In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.

September 22, 2022
|
By:
  • Jon Hamilton
A booster dose of the Moderna COVID-19 vaccine is prepared during a vaccination clinic on Dec. 29 in Lawrence, Mass. The FDA is now shortening the wait time between the second dose and the booster to five months from six months.

Tagged as: 

  • Health

FDA shortens the wait time between Moderna vaccine and booster to 5 months

Now, both the Pfizer and the Moderna booster shots can be given five months after the second dose of vaccine — down from six months.

January 07, 2022
|
By:
  • Deepa Shivaram
Federal regulators have granted an emergency use authorization to the vaccine developed by Moderna, whose Cambridge, Mass., headquarters are seen here.

Tagged as: 

  • Medical Treatments

Moderna's COVID-19 Vaccine Becomes 2nd To Earn FDA Authorization

The Food and Drug Administration greenlights the biotech firm's vaccine for emergency use in the U.S. The move bolsters a vast inoculation effort that's already underway.

December 18, 2020
|
By:
  • Colin Dwyer
Health care workers have been throwing out the excess vaccine, fearing it would be against FDA rules to use it.

Tagged as: 

  • Medical Treatments

Some Vials Of COVID-19 Vaccine Contain Extra Doses, Expanding Supply, FDA Says

The Food and Drug Administration says is advising health workers to use "every full dose obtainable" to help speed up the nationwide immunization campaign.

December 17, 2020
|
By:
  • Vanessa Romo
An example of a vial that will carry the COVID-19 vaccine produced by Pfizer and BioNTech sits on display during a Senate subcommittee hearing Thursday.

Tagged as: 

  • Medical Treatments

FDA Authorizes COVID-19 Vaccine For Emergency Use In U.S.

Pfizer and BioNTech's vaccine is the first to receive an emergency authorization from the Food and Drug Administration. Officials say it may be ready for widespread inoculations within days.

December 11, 2020
|
By:
  • Colin Dwyer
A nurse prepares to administer the Pfizer-BioNTech COVID-19 vaccine at a hospital in London on Tuesday. The Food and Drug Administration is considering a recommendation to authorize the vaccine in the United States.

Tagged as: 

  • Health

FDA Adviser: Vaccine To Be OK'd In Days, But 'Normal' May Not Return Until Next Fall

The Food and Drug Administration's authorization of a COVID-19 vaccine could come in a day or two, a member of an FDA expert panel says. But he says it may be late 2021 before normalcy returns.

December 11, 2020
|
By:
  • Noel King
The pharmaceutical giant Pfizer is formally requesting federal approval for emergency use of the company's COVID-19 vaccine

Tagged as: 

  • Medical Treatments

Pfizer Asks FDA To Approve Its COVID-19 Vaccine For Emergency Use

The pharmaceutical giant and partner BioNTech announced Friday that they are submitting a formal request to the Food and Drug Administration, just days after the vaccine was shown to be 95% effective.

November 20, 2020
|
By:
  • Colin Dwyer
The Federal Trade Commission has sent warning letters to several companies that marketed the drug thymosin alpha-1 as a purported treatment for COVID-19. The Food and Drug Administration has never approved the drug for any condition.

Tagged as: 

  • Investigations

Federal Trade Commission Cracks Down On Unproven COVID-19 Treatment

The Federal Trade Commission issued warning letters to several companies that marketed an unproven drug to treat COVID-19. Sales of the nonapproved drug, thymosin alpha-1, were first reported by NPR.

November 12, 2020
|
By:
  • Tom Dreisbach
Congressman Raja Krishnamoorthi, an Illinois Democrat, is calling on the Food and Drug Administration and the Federal Trade Commission to investigate sales of a non-FDA approved drug marketed as a treatment for COVID-19.

Tagged as: 

  • Investigations

Congressman Calls For Federal Crackdown On Unproven Coronavirus Treatment

An NPR investigation revealed a network of doctors marketing a non-FDA approved drug as a purported treatment for COVID-19. Now, Rep. Raja Krishnamoorthi (D-Ill.) is calling for federal enforcement.

October 28, 2020
|
By:
  • Tom Dreisbach
A worker works inside a lab at the SinoVac vaccine factory in Beijing on Thursday, Sept. 24, 2020. SinoVac, one of China's pharmaceutical companies behind a leading COVID-19 vaccine candidate, says its vaccine will be ready by early 2021 for distribution worldwide, including the U.S.

Tagged as: 

  • Politics

Political Rewind: The Politicization Of Public Health

Friday on Political Rewind: The Centers for Disease Control and Prevention (CDC) has been the gold standard of global public health organizations for many decades. But recent efforts to marginalize and undermine such trusted public health agencies — including the U.S. Food and Drug Administration (FDA) — are complicating the COVID-19 response.

How does this affect Americans' perceptions and the country's ability to combat coronavirus, particularly when a vaccine does become available? We discuss the politicization of a pandemic.

September 25, 2020
|
By:
  • Bill Nigut ,
  • Emilia Brock ,
  • and 1 more
Food and Drug Administration Commissioner Stephen Hahn drew a hailstorm of criticism from scientists this week for mischaracterizing a study's findings in a way that hyped the benefits of convalescent plasma. He later apologized, but critics say the damage was done.

Tagged as: 

  • Health

FDA's Hahn Apologizes For Overselling Plasma's Benefits As A COVID-19 Treatment

The Food and Drug Administration's chief said Sunday the therapy reduces deaths among COVID-19 patients by 35%. On Monday he apologized, acknowledging that statistic greatly exaggerates any benefit.

August 25, 2020
|
By:
  • Richard Harris

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