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Management: Food and Drug Administration (FDA)
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Total 1725 results found since Jan 2013.
Moderna Is Applying for Emergency F.D.A. Approval for Its Coronavirus Vaccine
The first shots could be given as early as Dec. 21, if authorization is granted.
Source: NYT Health - November 30, 2020 Category: Consumer Health News Authors: Denise Grady Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Research RNA (Ribonucleic Acid) Food and Drug Administration Moderna Inc National Institute of Allergy and Infectious Diseases your-feed-healthcare Source Type: news
Moderna to Begin Testing Its Coronavirus Vaccine in Children
The company said the trial would involve children ages 12 through 17.
Source: NYT Health - December 2, 2020 Category: Consumer Health News Authors: Denise Grady Tags: Clinical Trials Vaccination and Immunization Children and Childhood Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Food and Drug Administration Moderna Inc your-feed-healthcare Source Type: news
Pfizer ’s Vaccine Offers Strong Protection After First Dose
The Food and Drug Administration ’s first analysis of the clinical trial data also found that the coronavirus vaccine worked well regardless of a volunteer’s race, weight or age.
Source: NYT Health - December 8, 2020 Category: Consumer Health News Authors: Noah Weiland and Carl Zimmer Tags: Clinical Trials Vaccination and Immunization Coronavirus (2019-nCoV) Food and Drug Administration Pfizer Inc BioNTech SE Source Type: news
FDA chief reportedly urged by White House to approve Pfizer vaccine or quit
Mark Meadows said to have leaned on Stephen Hahn FridayFDA reportedly speeds up timetable for potential approvalWhite House chief of staff Mark Meadows has reportedly told the head of the US Food and Drug Administration to authorize Pfizer ’s coronavirus vaccine on Friday or prepare to resign.Related:White House told FDA chief to approve Pfizer vaccine or resign, reports say – liveContinue reading...
Source: Guardian Unlimited Science - December 11, 2020 Category: Science Authors: Tom McCarthy and agencies Tags: Coronavirus Vaccines and immunisation US news Infectious diseases Medical research US politics Donald Trump World news Source Type: news
Pfizer and FDA in negotiations before coronavirus vaccine authorization
Pfizer and the US Food and Drug Administration are "negotiating" what information should be on the label for the company's coronavirus...
Source: Reuters: Health - December 11, 2020 Category: Consumer Health News Source Type: news
Pregnant and Breastfeeding Women May Opt to Receive the Vaccine
Although no coronavirus vaccine has been studied in these women, many scientists believe the benefits will outweigh any potential risks.
Source: NYT Health - December 12, 2020 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: your-feed-science Pregnancy and Childbirth Clinical Trials Vaccination and Immunization Breastfeeding Coronavirus (2019-nCoV) Food and Drug Administration Pfizer Inc Source Type: news
Rapid Implementation of Severe Acute Respiratory Syndrome Coronavirus 2 Emergency Use Authorization RT-PCR Testing and Experience at an Academic Medical Institution
We present a detailed overview of the clinical validation and implementation of the first laboratory-developed real-time RT-PCR test offered in the NewYork-Presbyterian Hospital system following the Emergency Use Authorization issued by the US Food and Drug Administration.
Source: Journal of Molecular Diagnostics - December 4, 2020 Category: Pathology Authors: Priya Velu, Arryn Craney, Phyllis Ruggiero, John Sipley, Lin Cong, Erika M. Hissong, Massimo Loda, Lars F. Westblade, Melissa Cushing, Hanna Rennert Tags: Regular article Source Type: research
Did You Get the Coronavirus Vaccine, or Are You Planning To?
The New York Times would like to hear from people in the U.S. who received a vaccination against Covid-19, or hoped to get one.
Source: NYT Health - December 14, 2020 Category: Consumer Health News Authors: Abby Goodnough Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Pfizer Inc Food and Drug Administration Source Type: news
U.S. Vaccinations Ramp Up as Second COVID-19 Shot Nears
By MATTHEW PERRONE AP Health Writer
WASHINGTON (AP) — Hundreds more U.S. hospitals are set to begin vaccinating their workers Tuesday as federal regulators issued a positive review of a second COVID-19 vaccine shot needed to boost the nation’s largest vaccination campaign.
The Food and Drug Administration said in documents posted online that its initial review confirmed the effectiveness and safety of the vaccine developed by Moderna and the National Institutes of Health, bringing the shot to the cusp of U.S. authorization.
A panel of outside experts will offer their recommendation Thursday, with a final FDA d...
Source: JEMS Patient Care - December 15, 2020 Category: Emergency Medicine Authors: JEMS Staff Tags: AP News Coronavirus Hospital Medicine Source Type: news
Moderna Vaccine Is Highly Protective and Prevents Severe Covid, Data Show
The positive review most likely ensures that the Food and Drug Administration will grant emergency authorization to a second coronavirus vaccine this week for millions of Americans.
Source: NYT Health - December 15, 2020 Category: Consumer Health News Authors: Noah Weiland, Denise Grady and Carl Zimmer Tags: Clinical Trials Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) United States Politics and Government AstraZeneca PLC Food and Drug Administration Moderna Inc National Institutes of Health your-feed-healthcare Source Type: news
U.S. Vaccinations Ramp Up as Second COVID-19 Shot Nears
By MATTHEW PERRONE AP Health Writer
WASHINGTON (AP) — Hundreds more U.S. hospitals are set to begin vaccinating their workers Tuesday as federal regulators issued a positive review of a second COVID-19 vaccine shot needed to boost the nation’s largest vaccination campaign.
The Food and Drug Administration said in documents posted online that its initial review confirmed the effectiveness and safety of the vaccine developed by Moderna and the National Institutes of Health, bringing the shot to the cusp of U.S. authorization.
A panel of outside experts will offer their recommendation Thursday, with a final FDA d...
Source: JEMS Latest News - December 15, 2020 Category: Emergency Medicine Authors: JEMS Staff Tags: AP News Coronavirus Hospital Medicine Source Type: news
