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NEWS & BLOGS
Blog: Blog2
![[FDA News] New Announcement: You Can Now Opt to Use eSTAR for 513(g) Information Requests](https://static.wixstatic.com/media/7ffba2_2afeb0a820404b24912d1a7b592e4fa6~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_auto/7ffba2_2afeb0a820404b24912d1a7b592e4fa6~mv2.jpg)
Provision Consulting Group
Apr 1, 20242 min read
[FDA News] New Announcement: You Can Now Opt to Use eSTAR for 513(g) Information Requests
Date: 4/1/2024 Great news! Starting March 29, 2024, you can choose to use eSTAR for your 513(g) requests for information to CDRH. But...
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![[FDA News] The FDA has established the OTC (Over-the-Counter) Drug Monograph Facility User Fee rates for Fiscal Year (FY) 2024, and they have increased!](https://static.wixstatic.com/media/7ffba2_bd0f642500ca48aeb5d6f261322c808f~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_auto/7ffba2_bd0f642500ca48aeb5d6f261322c808f~mv2.jpg)
Provision Consulting Group
Mar 28, 20241 min read
[FDA News] The FDA has established the OTC (Over-the-Counter) Drug Monograph Facility User Fee rates for Fiscal Year (FY) 2024, and they have increased!
Date: 3/28/2024 FDA has announced the OTC (Over-the-Counter) Drug Monograph Facility User Fee rates for Fiscal Year (FY) 2024, and...
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![[FDA News] Unlocking Compliance: Labeling Changes for OTC NDAs/ANDAs - Plus AR Reporting Examples](https://static.wixstatic.com/media/7ffba2_49aae8e716e34df4a3974125889de3bc~mv2.jpg/v1/fill/w_1200,h_677,fp_0.50_0.50,q_90,enc_auto/7ffba2_49aae8e716e34df4a3974125889de3bc~mv2.jpg)
Provision Consulting Group
Mar 12, 20242 min read
[FDA News] Unlocking Compliance: Labeling Changes for OTC NDAs/ANDAs - Plus AR Reporting Examples
Date: 3/12/2024 Today, the FDA has issued a new guidance titled "Annual Reportable Labeling Changes for NDAs and ANDAs for...
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![[FDA News] SNAKE BONES Anti-Rheumatic Capsules contain hidden drug ingredient](https://static.wixstatic.com/media/7ffba2_abd49356a3fe443196c2564d277cae4f~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_auto/7ffba2_abd49356a3fe443196c2564d277cae4f~mv2.jpg)
Provision Consulting Group
Mar 6, 20242 min read
[FDA News] SNAKE BONES Anti-Rheumatic Capsules contain hidden drug ingredient
Date: 3/6/2024 The FDA cautioned consumers against using QUICK Rheumatism Capsule, Tiger Wang Biaod, or SNAKE BONES Anti-Rheumatic...
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![[FDA News] FDA Raises Concerns Regarding the Safe Utilization of Smartwatches and Smart Rings for Blood Glucose Monitoring.](https://static.wixstatic.com/media/7ffba2_427fb3ef84c24df2b8f384f7581e9434~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_auto/7ffba2_427fb3ef84c24df2b8f384f7581e9434~mv2.jpg)
Provision Consulting Group
Feb 28, 20242 min read
[FDA News] FDA Raises Concerns Regarding the Safe Utilization of Smartwatches and Smart Rings for Blood Glucose Monitoring.
Date: 2/28/2024 It's crucial to pay attention to the recent FDA warning regarding smartwatches and smart rings claiming to measure blood...
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![[FDA News] FDA urges medical device manufacturers to thoroughly review third-party-generated data amid concerns over fraudulent and unreliable laboratory testing data in premarket submissions.](https://static.wixstatic.com/media/7ffba2_8f8a669f89864c49b6f836e39bda64f6~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_auto/7ffba2_8f8a669f89864c49b6f836e39bda64f6~mv2.jpg)
Provision Consulting Group
Feb 22, 20242 min read
[FDA News] FDA urges medical device manufacturers to thoroughly review third-party-generated data amid concerns over fraudulent and unreliable laboratory testing data in premarket submissions.
Date: 2/22/2024 Today, we're excited to share some insightful updates from the U.S. Food and Drug Administration (FDA) that have...
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![[FDA News] Easing the Burden for Small Medical Device Businesses! - FDA's draft guidance document](https://static.wixstatic.com/media/ea2ded871fb834580ae155324f58345d.jpg/v1/fill/w_1280,h_722,fp_0.50_0.50,q_90,enc_auto/ea2ded871fb834580ae155324f58345d.jpg)
Provision Consulting Group
Feb 21, 20242 min read
[FDA News] Easing the Burden for Small Medical Device Businesses! - FDA's draft guidance document
Date: 2/21/2024 Guess what? The FDA just dropped some exciting news for small medical device businesses! They've released a draft...
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![[FDA News] FDA Approves First Medication to Treat Severe Frostbite](https://static.wixstatic.com/media/7ffba2_130efa122e8f4da19126469fdd7e8c54~mv2.jpg/v1/fill/w_1018,h_574,fp_0.50_0.50,q_90,enc_auto/7ffba2_130efa122e8f4da19126469fdd7e8c54~mv2.jpg)
Provision Consulting Group
Feb 14, 20242 min read
[FDA News] FDA Approves First Medication to Treat Severe Frostbite
Date: 2/14/2024 Frostbite is a severe condition that can lead to amputation of the affected fingers or toes. However, there is now new...
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![[FDA News] FDA Assembles Meeting to Address Concerns Over Pulse Oximeters' Accuracy in Darker-Skinned Individuals](https://static.wixstatic.com/media/7ffba2_01d94a3c4635441981ec0cedd546861e~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_auto/7ffba2_01d94a3c4635441981ec0cedd546861e~mv2.jpg)
Provision Consulting Group
Feb 12, 20242 min read
[FDA News] FDA Assembles Meeting to Address Concerns Over Pulse Oximeters' Accuracy in Darker-Skinned Individuals
Date: 2/12/2024 The Food and Drug Administration (FDA) recently convened a meeting to address growing concerns surrounding the accuracy...
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![[FDA News] The FDA has identified a single cinnamon processor as the likely source of lead contamination in the recalled applesauce pouches](https://static.wixstatic.com/media/7ffba2_ea7dae0862c045bbaf320b485c641922~mv2.png/v1/fill/w_743,h_419,fp_0.50_0.50,lg_1,q_95,enc_auto/7ffba2_ea7dae0862c045bbaf320b485c641922~mv2.png)
Provision Consulting Group
Feb 7, 20242 min read
[FDA News] The FDA has identified a single cinnamon processor as the likely source of lead contamination in the recalled applesauce pouches
Date: 2/7/2024 The FDA revealed on Tuesday that WanaBana's recalled cinnamon applesauce pouches, linked to lead poisoning cases in the...
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