Provision Consulting GroupApr 14, 20222 minFDA NewsFDA Authorizes First COVID-19 Diagnostic Test Using Breath SamplesApr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...
Provision Consulting GroupApr 13, 20223 minFDA RegulationsHow 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 GroupApr 8, 20222 minFDA RegulationsIn Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2Apr 08 2022 Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 This table includes information about authorized SARS-CoV-2...
Provision Consulting GroupApr 8, 20222 minFDA NewsFDA approves alpelisib for PIK3CA-related overgrowth spectrumApr 06 2022 On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis...
Provision Consulting GroupApr 5, 20222 minFDA NewsFDA updates Sotrovimab emergency use authorizationApr 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 GroupApr 4, 20223 minFDA RegulationsFY 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...