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Centers for Disease Control & Prevention (CDC)

COVID-19 vaccine booster tensions mount between White House, CDC and FDA

September 15, 2021 By Brian Buntz

Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.  But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.  Two departing senior FDA vaccine officials recently co-wrote […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, CDC, Centers for Disease Control & Prevention (CDC), COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, FDA, Pfizer

United, Abbott partner to use rapid COVID-19 test for international travel

May 13, 2021 By Sean Whooley

United Airlines and Abbott announced a collaboration to use the latter’s BinaxNOW COVID-19 home test to make international travel more seamless. Recent CDC guidelines permit travelers to self-administer a rapid antigen test under the real-time supervision of a telehealth service and use the verified negative result to board an international flight to the U.S., according […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics Tagged With: Abbott, Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19

More than 5 million skipped getting second COVID-19 vaccine dose

April 26, 2021 By Brian Buntz

The percentage of people who failed to get the second dose of Pfizer or Moderna COVID-19 vaccines is growing, according to recent CDC data. Some five million people, or almost 8% of people who got the first vaccine dose, missed getting the second. In mid-March, 3% of people were overdue for their second dose. People […]

Filed Under: Featured, Pharmaceutical Tagged With: Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccines

FDA, CDC lift pause on J&J COVID-19 vaccine

April 26, 2021 By Sean Whooley

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern. On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, COVID-19 vaccine, FDA, Janssen Pharmaceuticals, Johnson & Johnson

Feds halt J&J COVID-19 vaccine due to blood clot concern

April 13, 2021 By Sean Whooley

The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine. As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: CDC, Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, COVID-19 vaccine, FDA, Johnson & Johnson, U.S. Centers for Disease Control and Prevention (CDC)

Biden to put $12B toward COVID testing

March 17, 2021 By Nancy Crotti

The Biden administration today pledged $10 billion for school COVID-19 screenings and $2.25 billion for screenings and diagnostic testing among underserved populations. The money is part of the $1.9 trillion American Rescue Plan Act that Biden signed into law last week. The Department of Health and Human Services will divvy up the $10 billion among […]

Filed Under: Business/Financial News, Diagnostics, Distribution, Featured Tagged With: AdvaMed, Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, Dept. of Health & Human Services (HHS), FDA, Joe Biden

House Dems subpoena Azar, Redfield on questions of political pressure at CDC

December 21, 2020 By Nancy Crotti

A Congressional committee subpoenaed top Trump administration officials today, demanding documents they allege could show “extensive” pandemic-related political interference at the CDC. In a letter to Health and Human Services secretary Alex Azar and Centers for Disease Control and Prevention director Dr. Robert Redfield, House Democrats said an investigation showed that efforts to interfere with […]

Filed Under: Featured, Legal News Tagged With: Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, Dept. of Health & Human Services (HHS), U.S. House of Representatives

The top 5 MassDevice stories of the week — December 11, 2020

December 11, 2020 By Sean Whooley

The medtech industry continues to plug along as major news comes in about vaccines, the incoming presidential administration and more. This week’s top stories include the latest on COVID-19, Joe Biden and some additional FDA clearances, plus a major royalties spat. Want to hear more about the week’s top medtech news on MassDevice? Tom Salemi will […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Legal News, Neurological, Neuromodulation/Neurostimulation, Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, Boston Scientific, Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, Dept. of Health & Human Services (HHS), FDA, Joe Biden, Medtronic, Pfizer, Quest Diagnostics Inc.

Biden makes picks for HHS secretary, CDC director

December 7, 2020 By Sean Whooley

President-elect Joe Biden has made selections for leaders of the U.S. Dept. of Health & Human Services and the Centers for Disease Control & Prevention. Biden chose California Attorney General Xavier Becerra as his nominee for HHS secretary. The 12-term veteran of U.S. Congress had previously advocated for healthcare issues as AG in California and […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, Dept. of Health & Human Services (HHS), FDA, Joe Biden

Siemens, CDC team on standardizing COVID-19 antibody assays

September 15, 2020 By Sean Whooley

Siemens Healthineers (ETR:SHL) announced today that it is collaborating with the CDC and the JRC on a project to standardize COVID-19 assays. The collaboration with the CDC and Europe’s Joint Research Centre (JRC) is slated to develop a novel process for standardizing the SARS-CoV-2 antibody tests as they differ among manufacturers and currently can’t e analytically […]

Filed Under: Diagnostics, Featured, Genomics/Molecular Diagnostics Tagged With: Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, European Union Joint Research Centre (JRC), Siemens Healthineers

How decontamination could solve the COVID-19 mask shortage problem

September 4, 2020 By Nancy Crotti

With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks. A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks. Hundreds of […]

Filed Under: Featured, Food & Drug Administration (FDA), Research & Development, Respiratory, Sterilization / Calibration Tagged With: Association for Biosafety and Biosecurity, Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, FDA, Michigan State University, Public Health Agency of Canada

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