FDA Warning Letter: Regulatory Concerns for Eye Health Products on Amazon.com
Date: 11/22/2023 In the realm of regulatory scrutiny, our attention is drawn to a recent development where Amazon is a central figure—the...
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NEWS & BLOGS
Blog: Blog2
![[FDA News] October 12th Webinar_Use of ISO 10993-1 (Biocompatibility) Final Guidance](https://static.wixstatic.com/media/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg/v1/fill/w_999,h_667,fp_0.50_0.50,q_90,enc_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg)
Provision Consulting Group
Oct 6, 20231 min read
[FDA News] October 12th Webinar_Use of ISO 10993-1 (Biocompatibility) Final Guidance
The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the final guidance Use of...
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Provision Consulting Group
Jul 22, 20224 min read
FDA Announces Future Format of the National Drug Code
July 22 2022 On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label...
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Provision Consulting Group
Jun 14, 20222 min read
FDA warns Artri and Ortiga products, which may contain hidden drug ingredients
Jun 14 2022 FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to...
102
Provision Consulting Group
May 25, 20222 min read
FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia
May 25 2022 The Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed...
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Provision Consulting Group
May 11, 20222 min read
FDA approves OCS(Organ Care System) Heart System new medical technology
May 11 2022 The U.S. Food and Drug Administration(FDA) granted PMA(Premarket Approval) for OCS Heart System its donor hearts for...
35
Provision Consulting Group
May 5, 20224 min read
FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease
05 05 2022 The U.S. Food and Drug Administration permitted marketing for the first in vitro diagnostic test for early detection of...
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Provision Consulting Group
May 2, 20223 min read
Counterfeit At-Home OTC COVID-19 Diagnostic Tests
May 02 2022 The FDA is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the...
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Provision Consulting Group
Apr 29, 20222 min read
FDA approves new drug to improve heart function in adults with rare heart condition
Apr 29 2022 FDA has approved Camzyos (mavacamten) capsules to treat adults with symptomatic New York Heart Association (NYHA)External...
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Provision Consulting Group
Apr 27, 20222 min read
FDA Approves First COVID-19 Treatment for Young Children
Apr 27 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include...
21
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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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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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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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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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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Provision Consulting Group
Mar 25, 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....
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Provision Consulting Group
Mar 25, 20221 min read
FDA, Additional Procedural Notice on Consumer Research on “Healthy” Symbol
Mar 25 2022 FDA Issues Additional Procedural Notice on Consumer Research on “Healthy” Symbol. The U.S. Food and Drug Administration is...
26
Provision Consulting Group
Mar 24, 20222 min read
FDA approves Pluvicto for metastatic castration-resistant prostate cancer
Mar 24 2022 On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced...
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Provision Consulting Group
Mar 15, 20222 min read
FDA Approves First Generic of Symbicort to Treat Asthma and COPD
Mar 15 2022 On March 15 2022, The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol...
22
Provision Consulting Group
Mar 14, 20221 min read
FDA, FY 2022 OTC Monograph Drug User Fee(OMUFA)
Mar 14 2022 On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022. OTC...
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