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4 days ago

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 ea...

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

Provision Consulting Group

Sep 4

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 Dru...

FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

Provision Consulting Group

Sep 2

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 w...

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

Provision Consulting Group

Sep 2

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

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 Octobe...

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

Provision Consulting Group

Aug 18

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 S...

FDA Permits First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

Provision Consulting Group

Aug 7

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...

FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

Provision Consulting Group

Aug 7

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 ...

FDA Reissues EUA Revising Which Types of Respirators Can Be Decontaminated for Reuse

Provision Consulting Group

Aug 1

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 reissuin...

FDA recalls hand sanitizer products that have tested positive for methanol contamination

Provision Consulting Group

Aug 1

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 ...

Another FDA study shows the body absorbs chemicals in sunscreen products

Provision Consulting Group

Aug 1

Another FDA study shows the body absorbs chemicals in sunscreen products

Before slathering on sunscreen by the pool or on the golf course, consider this -- another study suggests you could be injecting chemica...

How You Can Make a Difference During the Coronavirus Pandemic

Provision Consulting Group

Jul 13

How You Can Make a Difference During the Coronavirus Pandemic

Image Source: https://www.fda.gov/consumers/consumer-updates/how-you-can-make-difference-during-coronavirus-pandemic

Provision Consulting Group

Jul 1

Coronavirus Disease 2019 (COVID-19)

2019 Novel Coronavirus (2019-nCoV) is a virus (more specifically, a coronavirus) identified as the cause of an outbreak of respiratory il...

Peanut Allergy for Children: FDA Approves First Drug for Treatment

Provision Consulting Group

Jul 1

Peanut Allergy for Children: FDA Approves First Drug for Treatment

On January 31, 2020, the U.S. Food and Drug Administration approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigat...

What is the FDA?: A Brief Introduction of the FDA

Provision Consulting Group

Jul 1

What is the FDA?: A Brief Introduction of the FDA

What is FDA? The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services, one of the...

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