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NEWS & BLOGS
Blog: Blog2
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar
The questions regarding Over-The-Counter Monograph Drug User Fee from related establishments have been radically increasing. The FDA is...
Provision Consulting Group
May 28, 20211 min read
FDA Warns Not Using Certain Needles With Safety Devices Made by HAIOU
The U.S. Food and Drug Administration on Thursday asked healthcare providers to stop using certain syringes and needles manufactured by...
Provision Consulting Group
May 26, 20212 min read
FDA authorizes use of the Pfizer-BioNTech Covid Vaccine in adolescents ages 12 to 15
On May 10, 2021, the U.S. Food and Drug Administration permits the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in kids ages 12...
Provision Consulting Group
May 19, 20212 min read
FDA Approves Treatment for Chronic Kidney Disease
On April 3, 2021, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney...
Provision Consulting Group
May 5, 20213 min read
Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr....
Provision Consulting Group
Apr 15, 20212 min read
New OTC Monograph User Fees for FY2021 is Announced
BACKGROUND On March 27, 2020, "the Coronavirus Aid, Relief, and Economic Security Act" (CARES Act) was signed into law. Section 744M of...
Provision Consulting Group
Apr 7, 20213 min read
FDA Alerts Public about Improper Use of Thermal Imaging Devices
The U.S. Food and Drug Administration alerted public of thermal imaging systems intended to measure human body temperature—also known as...
Provision Consulting Group
Mar 24, 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)....
Provision Consulting Group
Mar 18, 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...
Provision Consulting Group
Feb 25, 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...
Provision Consulting Group
Feb 17, 20212 min read
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