NEWS | Provision FDA Consulting Group

3 days ago

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....

New OTC Monograph User Fees for FY2021 is Announced

Provision Consulting Group

Apr 7

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...

FDA Alerts Public about Improper Use of Thermal Imaging Devices

Provision Consulting Group

Mar 24

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...

FDA Granted Marketing Authorization of First COVID-19 Diagnostic Test Using De Novo Review Pathway

Provision Consulting Group

Mar 18

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)....

Homemade Infant Formula is not recommended by the FDA

Provision Consulting Group

Feb 25

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...

FDA Warns Seriously Toxic Hand Sanitizers Imported from Mexico

Provision Consulting Group

Feb 17

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...

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

Provision Consulting Group

Jan 29

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...

Over 300 COVID-19 Tests and Collection Kits Authorized by the FDA in 2020

Provision Consulting Group

Jan 15

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...

The Most Commonly Reported Side Effects of Pfizer-BioNTech COVID-19 Vaccine

Provision Consulting Group

Dec 29, 2020

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...

FDA authorizes Pfizer, First COVID-19 Vaccine in the United States

Provision Consulting Group

Dec 16, 2020

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...

The Basic Information about Face Masks, Surgical Masks, and Respirators

Provision Consulting Group

Dec 4, 2020

The Basic Information about Face Masks, Surgical Masks, and Respirators

There is an outbreak of respiratory disease caused by a novel coronavirus called “Coronavirus Disease 2019” (COVID-19) and it raised...

FDA authorizes first fully at-home COVID-19 test kit

Provision Consulting Group

Nov 18, 2020

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...

Pfizer COVID Vaccine 90 Percent Effective in Trials, Company May Request EUA by the End of November

Provision Consulting Group

Nov 12, 2020

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...

Hand Sanitizer in Food Pouch is Recalled

Provision Consulting Group

Oct 5, 2020

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...

FDA Introduces A New OTC Monograph User Fee Program (OMUFA)

Provision Consulting Group

Sep 17, 2020

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...

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs

Provision Consulting Group

Sep 4, 2020

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...

FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

Provision Consulting Group

Sep 2, 2020

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...

FDA Broadens EUA for Veklury to Include All Hospitalized Patients for Treatment of COVID-19

Provision Consulting Group

Sep 2, 2020

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...

FDA Medical Device User Fees Increase 7% for 2021 Fiscal Year

Provision Consulting Group

Aug 19, 2020

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...

FDA Issues EUA to Yale for SalivaDirect, A New Method of Saliva Sample Process

Provision Consulting Group

Aug 18, 2020

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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