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NEWS & BLOGS
Blog: Blog2
![[FDA News] CDRH Issues 2024 Safety and Innovation Reports](https://static.wixstatic.com/media/7ffba2_c9cdcd8444da4217853810e77df32229~mv2.png/v1/fill/w_940,h_530,fp_0.50_0.50,q_35,blur_30,enc_avif,quality_auto/7ffba2_c9cdcd8444da4217853810e77df32229~mv2.png)
![[FDA News] CDRH Issues 2024 Safety and Innovation Reports](https://static.wixstatic.com/media/7ffba2_c9cdcd8444da4217853810e77df32229~mv2.png/v1/fill/w_940,h_530,fp_0.50_0.50,q_95,enc_avif,quality_auto/7ffba2_c9cdcd8444da4217853810e77df32229~mv2.png)
[FDA News] CDRH Issues 2024 Safety and Innovation Reports
Date: 4/22/2023 On April 17, 2024, the FDA released two reports detailing its progress on advancing medical device safety and innovation....
Provision Consulting Group
Apr 22, 20241 min read
MoCRA: More Than Just Compliance, A Boost for the Cosmetics Industry
Date: 4/19/2024 The Modernization of Cosmetics Regulation Act (MoCRA) of 2022, implemented in December 2022, marks a significant shift in...
Provision Consulting Group
Apr 19, 20242 min read
Demystifying the FDA Initial Importer: A Key Role in Medical Device FDA Compliance
Read this, and you will understand the Food and Drug Administration's (FDA) Initial Importer for medical device stakeholders.
Provision Consulting Group
Apr 10, 20243 min read
FDA MoCRA Deadline is approaching - Make sure your cosmetic products meet the requirements - Start signing up now!
Date: 4/2/2024 Register your facility with the FDA by July 1, 2024 The Modernization of Cosmetics Regulation Act 2022 (MoCRA) extends the...
Provision Consulting Group
Apr 2, 20242 min read
![[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_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_2afeb0a820404b24912d1a7b592e4fa6~mv2.jpg)
![[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_avif,quality_auto/7ffba2_2afeb0a820404b24912d1a7b592e4fa6~mv2.jpg)
[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...
Provision Consulting Group
Apr 1, 20242 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!](https://static.wixstatic.com/media/7ffba2_bd0f642500ca48aeb5d6f261322c808f~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_bd0f642500ca48aeb5d6f261322c808f~mv2.jpg)
![[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_avif,quality_auto/7ffba2_bd0f642500ca48aeb5d6f261322c808f~mv2.jpg)
[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...
Provision Consulting Group
Mar 28, 20241 min read
![[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_30,blur_30,enc_avif,quality_auto/7ffba2_49aae8e716e34df4a3974125889de3bc~mv2.jpg)
![[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_avif,quality_auto/7ffba2_49aae8e716e34df4a3974125889de3bc~mv2.jpg)
[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...
Provision Consulting Group
Mar 12, 20242 min read
![[FDA News] SNAKE BONES Anti-Rheumatic Capsules contain hidden drug ingredient](https://static.wixstatic.com/media/7ffba2_abd49356a3fe443196c2564d277cae4f~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_abd49356a3fe443196c2564d277cae4f~mv2.jpg)
![[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_avif,quality_auto/7ffba2_abd49356a3fe443196c2564d277cae4f~mv2.jpg)
[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...
Provision Consulting Group
Mar 6, 20242 min read
![[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_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_427fb3ef84c24df2b8f384f7581e9434~mv2.jpg)
![[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_avif,quality_auto/7ffba2_427fb3ef84c24df2b8f384f7581e9434~mv2.jpg)
[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...
Provision Consulting Group
Feb 28, 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.](https://static.wixstatic.com/media/7ffba2_8f8a669f89864c49b6f836e39bda64f6~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_8f8a669f89864c49b6f836e39bda64f6~mv2.jpg)
![[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_avif,quality_auto/7ffba2_8f8a669f89864c49b6f836e39bda64f6~mv2.jpg)
[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...
Provision Consulting Group
Feb 22, 20242 min read
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