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NEWS & BLOGS
Blog: Blog2


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...
Provision Consulting Group
Nov 18, 20201 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...
Provision Consulting Group
Nov 11, 20202 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...
Provision Consulting Group
Oct 5, 20201 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...
Provision Consulting Group
Sep 16, 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...
Provision Consulting Group
Sep 4, 20202 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...
Provision Consulting Group
Sep 2, 20201 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...
Provision Consulting Group
Sep 2, 20203 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...
Provision Consulting Group
Aug 18, 20201 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...
Provision Consulting Group
Aug 18, 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...
Provision Consulting Group
Aug 6, 20202 min read
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