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NEWS & BLOGS
Blog: Blog2


FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
Apr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...
Provision Consulting Group
Apr 14, 20222 min read


How to prepare a De Novo Request?
Apr 12 2022 In the United States, successfully launching a product is as important as developing a new medical device. Let's take a look...
Provision Consulting Group
Apr 13, 20223 min read


In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
Apr 08 2022 Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 This table includes information about authorized SARS-CoV-2...
Provision Consulting Group
Apr 8, 20222 min read


FDA approves alpelisib for PIK3CA-related overgrowth spectrum
Apr 06 2022 On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis...
Provision Consulting Group
Apr 8, 20222 min read


FDA updates Sotrovimab emergency use authorization
Apr 05 2022 Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion...
Provision Consulting Group
Apr 5, 20222 min read


FY 2023-2027 FDA Medical Device User Fee Amendment (MDUFA V)
Apr 04 2022 On April 19, 2022, the United States Food and Drug Administration(FDA) will provide a virtual MDUFA V public meeting that is...
Provision Consulting Group
Apr 4, 20223 min read


Allergens in Cosmetics
Mar 29 2022 Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some...
Provision Consulting Group
Mar 29, 20222 min read


FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines
Mar 29 2022 The U.S. Food and Drug Administration(FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna...
Provision Consulting Group
Mar 29, 20224 min read


FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance With 21 CFR Part 4
Mar 28 2022 The U.S. Food and Drug Administration(FDA) issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding...
Provision Consulting Group
Mar 28, 20222 min read


FDA updates Sotrovimab emergency use authorization
Mar 25 2022 On March 25, 2022, FDA limits use of Sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant....
Provision Consulting Group
Mar 25, 20222 min read
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