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NEWS & BLOGS
Blog: Blog2
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![FDA, OTC skin lightening products](https://static.wixstatic.com/media/22ea40_7da8fe44d0ed46daa2880802a204fa52~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_7da8fe44d0ed46daa2880802a204fa52~mv2.webp)
Provision Consulting Group
Apr 19, 20223 min read
FDA, OTC skin lightening products
Apr 19 2022 FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing...
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![FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples](https://static.wixstatic.com/media/22ea40_286879e880044082b13e0af8cd5f681a~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_286879e880044082b13e0af8cd5f681a~mv2.webp)
Provision Consulting Group
Apr 14, 20222 min read
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...
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![How to prepare a De Novo Request?](https://static.wixstatic.com/media/22ea40_7008be778445422ea7724244a7295a37~mv2.png/v1/fill/w_454,h_256,fp_0.50_0.50,q_95,enc_auto/22ea40_7008be778445422ea7724244a7295a37~mv2.webp)
Provision Consulting Group
Apr 13, 20223 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...
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![In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2](https://static.wixstatic.com/media/22ea40_630626d750e748b5918adc0de8362e22~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_630626d750e748b5918adc0de8362e22~mv2.webp)
Provision Consulting Group
Apr 8, 20222 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...
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![FDA approves alpelisib for PIK3CA-related overgrowth spectrum](https://static.wixstatic.com/media/22ea40_88e5fd5d5753466ea66634f047f4f35e~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_88e5fd5d5753466ea66634f047f4f35e~mv2.webp)
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...
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![FDA updates Sotrovimab emergency use authorization](https://static.wixstatic.com/media/22ea40_554abdeb43314deeb38e2e6ce17e9583~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_554abdeb43314deeb38e2e6ce17e9583~mv2.webp)
Provision Consulting Group
Apr 5, 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...
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![FY 2023-2027 FDA Medical Device User Fee Amendment (MDUFA V)](https://static.wixstatic.com/media/22ea40_5756a0f129e845abb3b6038a97c5786a~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_5756a0f129e845abb3b6038a97c5786a~mv2.webp)
Provision Consulting Group
Apr 4, 20223 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...
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![Allergens in Cosmetics](https://static.wixstatic.com/media/22ea40_07c32cb612a84301a1bb398c4b48a919~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_07c32cb612a84301a1bb398c4b48a919~mv2.webp)
Provision Consulting Group
Mar 29, 20222 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...
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![FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines](https://static.wixstatic.com/media/22ea40_9ff867b79e6b4c84b82a3b8fae3c4bb5~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_9ff867b79e6b4c84b82a3b8fae3c4bb5~mv2.webp)
Provision Consulting Group
Mar 29, 20224 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...
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![FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance With 21 CFR Part 4](https://static.wixstatic.com/media/22ea40_44981f73b37b4092b1c472b1b60c32e2~mv2.jpg/v1/fill/w_454,h_256,fp_0.50_0.50,q_90,enc_auto/22ea40_44981f73b37b4092b1c472b1b60c32e2~mv2.webp)
Provision Consulting Group
Mar 28, 20222 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...
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