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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Oct 19, 20213 min read
FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology
Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid...
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Provision Consulting Group
Oct 13, 20211 min read
FDA approves add-on drug for adults with rare form of blood vessel inflammation
Action FDA has approved Tavneos (avacopan) as an add-on treatment to standard therapy including glucocorticoids for adult patients with...
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Provision Consulting Group
Oct 5, 20212 min read
FDA authorizes new over-the-counter home COVID-19 test
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home...
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Provision Consulting Group
Sep 28, 20212 min read
FDA approves add-on drug for ages 10 & up with rare forms of high cholesterol
FDA has approved Repatha (evolocumab) injection as an add-on treatment to diet alone or together with certain other therapies for...
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Provision Consulting Group
Sep 24, 20217 min read
FDA updates on sunscreen requirements
FDA regulates sunscreens, which are nonprescription drugs, to help make sure that consumers have access to safe and effective sun...
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Provision Consulting Group
Sep 23, 20215 min read
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to...
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Provision Consulting Group
Sep 21, 20212 min read
FDA Approves First Biosimilar to Treat Macular Degeneration Disease
The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab...
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Provision Consulting Group
Aug 27, 20212 min read
FDA authorizes baricitinib alone as treatment for COVID-19
Today, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for baricitinib (sold under the brand name...
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Provision Consulting Group
Aug 23, 20215 min read
FDA Approves Pfizer-BioNTech COVID-19 Vaccine as The First COVID-19 Vaccine
On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and...
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Provision Consulting Group
Jul 22, 20212 min read
Pfizer Issues a Voluntary Nationwide Recall of CHANTIX® Tablets Due to N-Nitroso Varenicline Content
July 19, 2021, FDA announced Pfizer's nationwide recall for 12 Lots of ' CHANTIX ' tablets, the smoking cessation treatment since the...
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Provision Consulting Group
Jul 16, 20213 min read
Johnson & Johnson Issues Voluntary Recall of Sunscreen Products Due to the Presence of Benzene
July 14, 2021 FDA announced Johnson & Johnson's recall of 5 Neutrogena, Aveeno sunscreen products due to testing identified low levels of...
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Provision Consulting Group
Jul 14, 20211 min read
Class action lawsuit filed over hair care products causing baldness and scalp damage
The hair care product line, OGX, is facing a class action lawsuit over containing toxic chemicals that allegedly caused hair loss and...
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Provision Consulting Group
Jun 9, 20211 min read
South Korea's Response to COVID-19
Picture from www.fda.gov/media/149334/download The FDA's Center for Devices and Radiological Health (CDRH) has issued a report that...
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Provision Consulting Group
May 28, 20211 min read
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...
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Provision Consulting Group
May 26, 20212 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...
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Provision Consulting Group
May 19, 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...
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Provision Consulting Group
May 5, 20213 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...
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Provision Consulting Group
Apr 15, 20212 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....
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Provision Consulting Group
Apr 7, 20213 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...
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Provision Consulting Group
Mar 24, 20212 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...
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