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Emergency Response

April 09, 2021 | Daily News

The Biden administration wants to enhance FDA’s “organizational capacity” as part of its larger goal of preparing the United States to respond to future public health crises.

April 02, 2021 | Daily News

The U.S. Office of Special Counsel, an independent federal investigative agency, told President Joe Biden and key congressional committees that a credible whistleblower complaint shows FDA watered down troubling inspection findings in at least four instances at biologics plants in recent years, including at a Merck plant that now produces Johnson & Johnson vaccines.

March 31, 2021 | Daily News

The Biden administration on Wednesday (March 31) unveiled a proposal to invest $30 billion over a four-year period in U.S. pandemic preparedness and response efforts that include shoring up the Strategic National Stockpile, developing and fielding tests and therapeutics for emerging outbreaks, and developing prototype vaccines through phase 1 and 2 trials.

March 25, 2021 | Daily News

HHS will stop distributing Eli Lilly’s COVID-19 monoclonal antibody bamlanivimab as a single therapy across the United States due to increased spread of COVID-19 variants that are resistant to bamlanivimab when it’s administered by itself, the department announced Wednesday (March 24).

March 23, 2021 | Daily News

Science and policy experts say HHS should stop distributing Eli Lilly’s FDA-authorized COVID-19 monoclonal antibody bamlanivimab throughout the United States as FDA has found the therapy is less effective against new strains of COVID-19 compared than are other emergency authorized antibody cocktails.

March 19, 2021 | Daily News

A top FDA official told Congress on Thursday (March 18) that FDA could feasibly authorize updates or changes to COVID-19 vaccines without requiring clinical studies in humans in the hopes of speeding the premarket regulation process to mitigate the spread of new strains of the virus.

March 19, 2021 | Daily News

Once COVID-19 vaccine booster shots become available, people with compromised immune systems and other preexisting health conditions likely will need to be first in line to get the shots since their antibody levels will wane faster than those of otherwise healthy people, National Institute of Allergy and Infectious Diseases Director Anthony Fauci told lawmakers during a Senate health committee hearing Thursday (March 18).

March 17, 2021 | Daily News

The Biden administration has directed HHS to invest over $12 billion in COVID-19 serial testing, $10 billion of which is allocated for asymptomatic screening testing in K-12 schools and $2.25 billion is set aside for testing underserved populations.

March 16, 2021 | Daily News

FDA is open to authorizing COVID-19 tests that can be used to regularly screen asymptomatic individuals at businesses and schools or at home, even if the tests have not been validated for use in asymptomatic patients, the agency announced Tuesday (March 16), saying it hopes the streamlined pathway to market will expand availability of screening tests and bolster testing programs.

March 08, 2021 | Daily News

In its first set of recommendations geared toward fully vaccinated individuals, the Centers for Disease Control and Prevention says that people who are fully vaccinated against COVID-19 can safely gather indoors without a mask with other fully vaccinated people or with unvaccinated members of a single low-risk household indoors.

March 05, 2021 | Daily News

Infectious disease experts stress the importance of applying the same urgency to pediatric COVID-19 vaccine trials and vaccination efforts that has been applied to adult studies and vaccinations in order to achieve the herd immunity needed to reopen the United States.

March 04, 2021 | Daily News

Congress’ investigative arm warned Wednesday (March 3) that FDA needs to prepare for a large backlog of foreign inspections in future years due to its decision to stop onsite reviews during the pandemic and rely on alternative inspection options, and it asked FDA to study whether the alternative tools have worked in place of traditional inspections.

March 04, 2021 | Daily News

Pediatricians say vaccine developers need to make information about their COVID-19 clinical trials more accessible, especially to historically underrepresented minority groups, to encourage parents to enroll their children in trials now taking place to study the vaccines’ effects on children.

February 26, 2021 | Daily News

CMS will consider provider-specific emergency waivers for Texas clinicians in Medicare and Medicaid due to the recent severe winter storms in the state, but the agency says it has already provided numerous waivers due to the COVID-19 pandemic, so it will not add any more blanket waivers.

February 25, 2021 | Daily News

Pfizer and BioNTech have begun studying whether adding a third shot, or a booster shot, to their two-dose COVID-19 vaccine could increase the vaccine’s effectiveness against new mutant strains of the virus, the companies announced Thursday (Feb. 25), just days after top FDA officials encouraged vaccine developers to begin testing booster shots as soon as possible to prepare for potentially resistant strains.

February 24, 2021 | Daily News

President Joe Biden has directed HHS and the Department of Defense to deliver more than 25 million masks to community health centers and food pantries across the United States to ensure disadvantaged communities have proper protection against COVID-19, the White House announced Wednesday (Feb. 24).

February 24, 2021 | Daily News

President Joe Biden will sign an executive order Wednesday (Feb. 24) afternoon calling for a 100-day review of the U.S. pharmaceutical supply chain in a bid to protect finished drug products and active pharmaceutical ingredients against a range of vulnerabilities, including overreliance on foreign competitors and diminished capacity.

February 22, 2021 | Daily News

FDA on Monday (Feb. 22) issued two new guidances and updated two existing guidances to guide COVID-19 test, vaccine and therapeutics developers on how to update their products to account for COVID-19 variants.

February 19, 2021 | Daily News

The Centers for Disease Control and Prevention released a report Friday (Feb. 19) stating it found no significant serious safety problems after its first month of monitoring those who received the two FDA-authorized COVID-19 vaccines, consistent with data from earlier vaccine clinical trials.

February 19, 2021 | Daily News

Due to inclement winter weather across much of the United States, especially in the south, the United States has a backlog of about 6 million doses of vaccine that are sitting at factories rather than being shipped out to states, White House COVID-19 Response Team Senior Adviser Andy Slavitt said Friday (Feb. 19).