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Agency of the United States Department of Health and Human Services

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Food and Drug Administration: Agency of the United States Department of Health and Human Services
The United States Food and Drug Administration is a Federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

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Gilead's remdesivir gets U.S. FDA approval [Video]

Gilead's remdesivir gets U.S. FDA approval

The U.S. Food and Drug Administration on Thursday approved Gilead Sciences's antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for..

Credit: Reuters Studio     Duration: 01:29Published
California to review any COVID-19 vaccine [Video]

California to review any COVID-19 vaccine

An independent panel of experts has been formed in California to review any federally approved Covid-19 vaccine. The move follows concerns that the White House could rush the process. Flora..

Credit: Reuters - Politics     Duration: 01:25Published
Twitter blocks post by top Trump pandemic adviser [Video]

Twitter blocks post by top Trump pandemic adviser

[NFA] Twitter took down a post by a top coronavirus task force adviser who questioned whether masks worked to cut down on transmission of the respiratory illness. This report produced by Zachary..

Credit: Reuters - Politics     Duration: 02:09Published
FDA faults quality control at Eli Lilly plant [Video]

FDA faults quality control at Eli Lilly plant

U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as..

Credit: Reuters Studio     Duration: 01:36Published
U.S. seeing 'clearly a resurgence' of coronavirus [Video]

U.S. seeing 'clearly a resurgence' of coronavirus

[NFA] The U.S. death toll from the coronavirus topped 213,000 and former FDA commissioner Scott Gottlieb said that the U.S. is in for a "difficult fall and winter." This report produced by Zachary..

Credit: Reuters - Politics     Duration: 01:33Published
FDA updates guidelines on coronavirus vaccine [Video]

FDA updates guidelines on coronavirus vaccine

The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates. Story:..

Credit: ABC Action News     Duration: 01:27Published
FDA, EU diverge on AstraZeneca COVID-19 vaccine [Video]

FDA, EU diverge on AstraZeneca COVID-19 vaccine

The Food and Drug Administration widened its probe into a serious illness linked to halted clinical trials for AstraZeneca's potential COVID-19 vaccine, sources told Reuters, while in Europe the..

Credit: Reuters Studio     Duration: 01:42Published
J&J launches final study of COVID-19 vaccine [Video]

J&J launches final study of COVID-19 vaccine

The drug giant said it would begin a stage three trial of a single-shot vaccine, which could prove easier to administer than rivals that require two inoculations. This report produced by Zachary..

Credit: Reuters - Politics     Duration: 01:09Published
Visby's COVID-19 test gets FDA approval [Video]

Visby's COVID-19 test gets FDA approval

Silicon Valley startup Visby Medical has received Emergency Use Authorization by the U.S. Food and Drug Administration for a portable COVID-19 test kit, the first company to do so. Gloria Tso reports.

Credit: Reuters Studio     Duration: 02:22Published
PM 'virtue signalling' with civil servants return call [Video]

PM 'virtue signalling' with civil servants return call

FDA General Secretary Dave Penman says the government is "virtue signalling" to the private sector following its calls for civil servants to return to the workplace. He also accused Boris Johnson or..

Credit: ODN     Duration: 01:23Published
PM ‘virtue signalling’ with civil servants return call [Video]

PM ‘virtue signalling’ with civil servants return call

FDA General Secretary Dave Penman says the government is “virtue signalling” to the private sector following its calls for civil servants to return to the workplace. He also accused Boris..

Credit: ODN     Duration: 01:23Published
McEnany: No one pressuring FDA to approve vaccine [Video]

McEnany: No one pressuring FDA to approve vaccine

White House Spokeswoman Kayleigh McEnany said on Thursday there is no political pressure on the U.S. drugs regulator to quickly approve a vaccine for the deadly coronavirus disease, after drugmakers..

Credit: Reuters Studio     Duration: 01:37Published
U.S. coronavirus cases top 6 million [Video]

U.S. coronavirus cases top 6 million

U.S. cases of the novel coronavirus surpassed 6 million on Sunday as many states in the Midwest reported increasing infections, according to a Reuters tally. This report produced by Yahaira Jacquez.

Credit: Reuters - Politics     Duration: 01:43Published
New Acne Cream Targets Hormones [Video]

New Acne Cream Targets Hormones

Early next year, dermatologists could have a new weapon with which to do battle against acne. According to Allure, the topical cream Winlevi was officially approved at the end of August by the United..

Credit: Wochit News     Duration: 00:34Published
S&P 500 Closes At Record High [Video]

S&P 500 Closes At Record High

On Thursday, the S&P 500 extended its record highs. Federal Reserve Chair Jerome Powell spoke at this year's virtual Jackson Hole symposium. Business Insider reports that Powell outlined the central..

Credit: Wochit News     Duration: 00:37Published

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This week on "Face the Nation," October 25, 2020

National Security Adviser Robert O'Brien, and FDA Commissioner Scott Gottlieb appear on Sunday's "Face the Nation"
CBS News - Published

FDA approves remdesivir as COVID-19 treatment

The Food and Drug Administration approved the antiviral drug remdesivir to treat adults who are hospitalized with COVID-19, although it has not been proven to reduce deaths. Dr. Bob Lahita joins CBSN..
CBS News - Published Also reported by •The VergeUSATODAY.com

Covid 19 coronavirus: FDA approves first drug: antiviral remdesivir

covid 19 coronavirus: fda approves first drug: antiviral remdesivir
US regulators on Thursday approved the first drug to treat Covid-19: remdesivir, an antiviral medicine given to hospitalised patients through an IV.The drug, which California-based Gilead Sciences is..
New Zealand Herald - Published

F.D.A. Approves Remdesivir as First Drug to Treat Covid-19

The move indicated that the drug had cleared more rigorous hurdles since it was given emergency authorization in May.
NYTimes.com - Published Also reported by •CBS NewsThe Verge

Health secretary denies report he wants to oust FDA head

According to a report published in Politico​, Azar had expressed his frustration with Hahn to several allies within his department
CBS News - Published

HHS Secretary Alex Azar on COVID-19 vaccine timeline and "concerning" pandemic trend

Coronavirus cases are increasing in nearly 75% of the U.S., according to the Centers for Disease Control. Health and Human Services Secretary Alex Azar joined "CBS This Morning" to discuss the..
CBS News - Published

Pharmaceutical executives face prison time for racketeering, after breaking FDA laws, enticing doctors to boost opioid sales

A former sales VP for a pharmaceutical company was sentenced to prison tells 60 Minutes he bribed doctors to prescribe fentanyl drugs. Bill Whitaker reports.
CBS News - Published

Did the FDA ignite the opioid epidemic?

A drug manufacturer denounces his own industry and explains to 60 Minutes how a label change by the FDA expanded the use of opioids. Bill Whitaker reports.
CBS News - Published

Doctor weighs in on coronavirus vaccine timeline, surge in U.S. cases

Moderna's CEO says interim results are expected next month from a large clinical trial of the company's coronavirus vaccine -- one of several vaccines in the final phase of testing. If all goes well,..
CBS News - Published

US trial of AstraZeneca Covid vaccine may resume this week - Report

us trial of astrazeneca covid vaccine may resume this week - report
AstraZeneca Plc's COVID-19 vaccine trial in the United States is expected to resume as early as this week after the U.S. Food and Drug Administration completed its review of a serious illness in a..
WorldNews - Published

Government agency will investigate Trump administration political influence over FDA, CDC

Both agencies have been caught in political crossfire since the start of the pandemic, as preventative health measures became politicized.
USATODAY.com - Published

Gottlieb says "biggest wave" of coronavirus infections still to come

The former FDA commissioner says the U.S. has "two or three very hard months ahead of us."
CBS News - Published

Transcript: Scott Gottlieb on "Face the Nation"

The following is a transcript of an interview with former FDA Commissioner Scott Gottlieb that aired October 18, 2020, on "Face the Nation."
CBS News - Published

Don't inject politics into vaccine policy

People are already suspicious about vaccines. Political pressure on the Food and Drug Administration will further undermine trust.
USATODAY.com - Published

Rapid research in a deadly epidemic pays off

rapid research in a deadly epidemic pays off
Image: CDC This week’s US Food and Drug Administration approval of an Ebola drug is a big milestone in drug development — one that’s closely tied to our current efforts to fight..
The Verge - Published

Pfizer will not seek COVID-19 vaccine authorization before election

Pfizer announced Friday it will apply for FDA emergency use authorization for its COVID-19 vaccine "soon after the safety milestone is achieved in the third week in November." Meg Oliver has details.
CBS News - Published

Pregnant women should not take ibuprofen after 20 weeks, FDA says. It could harm the baby's kidneys.

Some of the most commonly used pain and fever medications could cause fetal kidney problem at or after 20 weeks of pregnancy, according to the FDA.
USATODAY.com - Published

FDA approves first treatment for Ebola

fda approves first treatment for ebola
Image: CDC The Food and Drug Administration approved a drug tested during the 2018 Ebola epidemic as a treatment for the disease. It’s the first therapy approved by the agency for Ebola, and shows..
The Verge - Published

Johnson & Johnson pauses COVID-19 vaccine trial due to unexplained illness

johnson & johnson pauses covid-19 vaccine trial due to unexplained illness
Illustration by Ana Kova Johnson & Johnson’s clinical trial of its COVID-19 vaccine was paused after a volunteer came down with an unexplained illness. The company did not disclose what the..
The Verge - Published

Gottlieb predicts "a lot of death and disease" as COVID cases rise

The former FDA commissioner says the U.S. is "in a difficult situation heading into the fall" as the virus surges in parts of the country
CBS News - Published

What would be required to get Trump's new favorite COVID antibody treatment on the market?

President Trump touts an experimental COVID antibody cocktail made by Regeneron and wants it free for all Americans. The FDA can fast-track approval.
USATODAY.com - Published

Trump is promising free antibody treatments for everyone. It won’t be that simple.

trump is promising free antibody treatments for everyone. it won’t be that simple.
Coronavirus Trump is promising free antibody treatments for everyone. It won’t be that simple. The president is talking up the experimental therapies as the possibility of a coronavirus vaccine..
WorldNews - Published

Why Apple needed the FDA to sign off on its EKG but not its blood oxygen monitor

why apple needed the fda to sign off on its ekg but not its blood oxygen monitor
Sensors on the Apple Watch Series 6 monitor heart rate and blood oxygen levels. During the announcement of the Apple Watch Series 6, the company heralded the newest element — a blood oxygen..
The Verge - Published

Doctor on FDA's COVID vaccine guidelines and VP debate safety

The FDA has issued guidelines for coronavirus vaccine manufacturers which make it extremely unlikely that a vaccine will be approved before Election Day. And there's ongoing concern about the COVID-19..
CBS News - Published

A Dose of Vaccine Reality

The F.D.A. releases guidelines that had been trailed by politics: This is your morning tip sheet.
NYTimes.com - Published

FDA's new vaccine guidance that pushes approval past election

President Trump said Monday that a vaccine is coming "momentarily," but the FDA says more safety monitoring comes first.
CBS News - Published

FDA coronavirus vaccine guidelines raise doubts over approval by Election Day

Guidelines by the FDA all but close the door on having a coronavirus vaccine by Election Day. Meg Oliver reports.
CBS News - Published

CDC changes guidance on COVID-19, says airborne transmission is possible

The CDC has again updated its COVID-19 transmission guidance, saying the virus can travel farther than six feet though "airborne" transmission. At the FDA, career scientists are reportedly being..
CBS News - Published

Coronavirus: White House blocks FDA's Covid vaccine guidelines

coronavirus: white house blocks fda's covid vaccine guidelines
The White House has blocked new Food and Drug Administration (FDA) guidelines on bringing potential vaccines for Covid-19 to market that would almost certainly have prevented their approval before the..
New Zealand Herald - Published Also reported by •NYTimes.com

Gottlieb says those around Trump earlier in the week "not in the clear"

The former FDA commissioner says "anyone who was with the president Tuesday, Wednesday is not in the clear."
CBS News - Published

Is a coronavirus vaccine possible in 2020?

Pfizer says it could have results as soon as the end of October for its possible COVID vaccine. But health experts are concerned about avoiding any possible political interference in the process ahead..
CBS News - Published

Full transcript of "Face the Nation" on September 27, 2020

On this "Face the Nation" broadcast, White House Chief of Staff Mark Meadows and Former FDA Commissioner Scott Gottlieb sat down with Margaret Brennan
CBS News - Published

Gottlieb warns of "very dangerous season" for coronavirus as cases rise

The former FDA commissioner says the number of infections remains high heading into the fall and winter.
CBS News - Published

TikTok "Benadryl Challenge" prompts FDA warning on overdoses

Agency cites reports of teens hospitalized or dead from misuse of allergy medication in an attempt to get high.
CBS News - Published

Recalled mushrooms likely linked to salmonella outbreak shipped to restaurants in more than 30 states

The FDA and CDC are investigating a multi-state outbreak of salmonella infections that has sickened 41 and is likely linked to wood ear mushrooms.
USATODAY.com - Published

Trump says he may not OK stricter FDA standards for vaccine approval

Mr. Trump told reporters tightened standards from the FDA for an emergency use authorization for a coronavirus vaccine "sounds like a political move."
CBS News - Published

Oxford Covid vaccine: AstraZeneca still waiting for FDA nod to resume US trial

oxford covid vaccine: astrazeneca still waiting for fda nod to resume us trial
AstraZeneca is still waiting for the U.S. drug regulator to approve the restart of the clinical trial of its potential COVID-19 vaccine in the United States almost three weeks after it was paused due..
WorldNews - Published

Covid-19 News: Live Updates

President Trump said the White House “may or may not” approve new F.D.A. guidelines that would toughen the process for approving a coronavirus vaccine.
NYTimes.com - Published

Trump May Reject Tougher F.D.A. Vaccine Standards, Calling Them ‘Political’

In suggesting he might reject tougher guidelines, President Trump once again undermined efforts by government scientists to bolster public confidence in their work.
NYTimes.com - Published



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