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NEWS & BLOGS
Blog: Blog2
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
608
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
18
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
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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
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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
151
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
13
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
20
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...
Provision Consulting Group
Aug 6, 20202 min read
11
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...
Provision Consulting Group
Jul 31, 20203 min read
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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...
Provision Consulting Group
Jul 31, 20202 min read
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