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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Mar 18, 20212 min read
FDA Granted Marketing Authorization of First COVID-19 Diagnostic Test Using De Novo Review Pathway
On March 17, 2021, the U.S Food and Drug Administration permits marketing authorization of the BioFire Respiratory Panel 2.1 (RP 2.1)....
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Provision Consulting Group
Feb 25, 20212 min read
Homemade Infant Formula is not recommended by the FDA
On February 24, 2021, the FDA advises parents and caregivers to not make or feed homemade infant formula to infants. The FDA said that...
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Provision Consulting Group
Feb 17, 20212 min read
FDA Warns Seriously Toxic Hand Sanitizers Imported from Mexico
The Food and Drug Administration has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert. It is the first...
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Provision Consulting Group
Jan 29, 20212 min read
FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV
On January 21, The U.S. Food and Drug Administration approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a...
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Provision Consulting Group
Jan 15, 20211 min read
Over 300 COVID-19 Tests and Collection Kits Authorized by the FDA in 2020
Recently, the FDA revealed traces of their fiercest battle against the COVID-19 pandemic last year. "Our Center for Devices and...
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Provision Consulting Group
Dec 28, 20202 min read
The Most Commonly Reported Side Effects of Pfizer-BioNTech COVID-19 Vaccine
On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the...
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Provision Consulting Group
Dec 16, 20203 min read
FDA authorizes Pfizer, First COVID-19 Vaccine in the United States
On December 11, 2020, FDA authorized the first EUA (Emergency Use of Authorization) for a vaccine for COVID-19) for individuals 16 years...
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Provision Consulting Group
Nov 18, 20201 min read
FDA authorizes first fully at-home COVID-19 test kit
The Food and Drug Administration has authorized emergency use of the first at-home coronavirus test, which gives results back in about 30...
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Provision Consulting Group
Nov 11, 20202 min read
Pfizer COVID Vaccine 90 Percent Effective in Trials, Company May Request EUA by the End of November
On Monday Pfizer announced that its coronavirus vaccine developed with BioNTech SE prevented 90 % of infections in a trial with tens of...
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Provision Consulting Group
Oct 5, 20201 min read
Hand Sanitizer in Food Pouch is Recalled
Photo Courtesy of Nikki Teixeira, by Katie Kindelan, ABC News Last September, a mom in Canada was warning parents and caregivers after...
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Provision Consulting Group
Sep 16, 20202 min read
FDA Introduces A New OTC Monograph User Fee Program (OMUFA)
On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and...
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Provision Consulting Group
Sep 4, 20202 min read
FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and...
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Provision Consulting Group
Sep 2, 20201 min read
FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee...
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Provision Consulting Group
Sep 2, 20203 min read
FDA Broadens EUA for Veklury to Include All Hospitalized Patients for Treatment of COVID-19
On August 28, as part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration broadened the scope of the existing...
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Provision Consulting Group
Aug 18, 20201 min read
FDA Medical Device User Fees Increase 7% for 2021 Fiscal Year
FDA medical device user fees of both standard rates and small-business rates will slightly increase for 2021 fiscal year, which is...
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Provision Consulting Group
Aug 18, 20202 min read
FDA Issues EUA to Yale for SalivaDirect, A New Method of Saliva Sample Process
On August 15, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its...
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Provision Consulting Group
Aug 6, 20202 min read
FDA Permits First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
On June 15, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve...
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Provision Consulting Group
Aug 6, 20202 min read
FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection
On July 31, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of...
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Provision Consulting Group
Jul 31, 20203 min read
FDA Reissues EUA Revising Which Types of Respirators Can Be Decontaminated for Reuse
In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is...
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Provision Consulting Group
Jul 31, 20202 min read
FDA recalls hand sanitizer products that have tested positive for methanol contamination
FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled...
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