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NEWS & BLOGS
Blog: Blog2
Raphas, a Leading Microneedle Patch Manufacturer in South Korea, Achieves Outstanding FDA cGMP Inspection Results Through Collaboration with Provision Consulting Group
Date: 11/3/2023 Raphas, a leading innovator in microneedle patch technology, develops and applies its products across a wide range of...
Provision Consulting Group
Nov 10, 20232 min read
FDA Postpones Cosmetic Facility Registration Enforcement: Navigating MoCRA Compliance Landscape
Date: 11/10/2023 In a recent announcement on November 8, 2023, the FDA communicated a deferment in the enforcement date for cosmetic...
Provision Consulting Group
Nov 10, 20233 min read
![[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_1000,h_564,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg)
![[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_1000,h_564,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.jpg)
[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...
Provision Consulting Group
Oct 6, 20231 min read
![[FDA Regulatory] As of October 1, 2023, all FDA 510(k) submissions are mandatory through eSTAR.](https://static.wixstatic.com/media/7ffba2_ad9a1639f311453db9fdf92efe4465e6~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_ad9a1639f311453db9fdf92efe4465e6~mv2.jpg)
![[FDA Regulatory] As of October 1, 2023, all FDA 510(k) submissions are mandatory through eSTAR.](https://static.wixstatic.com/media/7ffba2_ad9a1639f311453db9fdf92efe4465e6~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_ad9a1639f311453db9fdf92efe4465e6~mv2.jpg)
[FDA Regulatory] As of October 1, 2023, all FDA 510(k) submissions are mandatory through eSTAR.
On October 2nd, the U.S. Food and Drug Administration (FDA) issued final guidance on the "Electronic Submissions Template for Medical...
Provision Consulting Group
Oct 2, 20231 min read
![[FDA MoCRA Special Contribution #5] Prepare Now! Key Steps for Ensuring Regulatory Compliance](https://static.wixstatic.com/media/nsplsh_80be2069f684450badb9e9ac1e852832~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/nsplsh_80be2069f684450badb9e9ac1e852832~mv2.jpg)
![[FDA MoCRA Special Contribution #5] Prepare Now! Key Steps for Ensuring Regulatory Compliance](https://static.wixstatic.com/media/nsplsh_80be2069f684450badb9e9ac1e852832~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/nsplsh_80be2069f684450badb9e9ac1e852832~mv2.jpg)
[FDA MoCRA Special Contribution #5] Prepare Now! Key Steps for Ensuring Regulatory Compliance
Date: 12/14/2023 In the cosmetics industry, staying updated on regulations is crucial, especially with the recent historical changes due...
Provision Consulting Group
Sep 22, 20232 min read
![[FDA MoCRA Special Contribution #2] Due is coming! Registration and Listing Requirement](https://static.wixstatic.com/media/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg)
![[FDA MoCRA Special Contribution #2] Due is coming! Registration and Listing Requirement](https://static.wixstatic.com/media/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_67b25b1232fc479fa4e76eeaf463a054~mv2.jpg)
[FDA MoCRA Special Contribution #2] Due is coming! Registration and Listing Requirement
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA's authority to regulate...
Provision Consulting Group
Sep 18, 20232 min read
![[FDA MoCRA Special Contribution #4] What to expect? Future Cosmetic Industry Trend](https://static.wixstatic.com/media/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg/v1/fill/w_1773,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg)
![[FDA MoCRA Special Contribution #4] What to expect? Future Cosmetic Industry Trend](https://static.wixstatic.com/media/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg/v1/fill/w_1816,h_1024,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_17ef56aec5fb4c62ba48e80ba0db3d88~mv2.jpg)
[FDA MoCRA Special Contribution #4] What to expect? Future Cosmetic Industry Trend
The Impact of the FDA's Modernization of Cosmetics Regulation Act (MoCRA) on the Future of the Cosmetics Market The FDA's Modernization...
Provision Consulting Group
Sep 18, 20232 min read
![[FDA MoCRA Special Contribution #3] FDA is now enforcing! FDA's Authority](https://static.wixstatic.com/media/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg/v1/fill/w_998,h_563,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg)
![[FDA MoCRA Special Contribution #3] FDA is now enforcing! FDA's Authority](https://static.wixstatic.com/media/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg/v1/fill/w_998,h_563,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_818f2c226c684133a22d63b0971698cc~mv2.jpg)
[FDA MoCRA Special Contribution #3] FDA is now enforcing! FDA's Authority
After 84 years, the FDA Modernization of Cosmetics Regulation Act (MoCRA) is being revised and is set to take effect on December 29,...
Provision Consulting Group
Sep 12, 20232 min read
![[FDA News] Webinar on September 12 - Qualification of Medical Device Development Tools](https://static.wixstatic.com/media/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg/v1/fill/w_1000,h_564,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg)
![[FDA News] Webinar on September 12 - Qualification of Medical Device Development Tools](https://static.wixstatic.com/media/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg/v1/fill/w_1000,h_564,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_038f30351dc148e9b0c4cc0e707b1c2c~mv2.jpg)
[FDA News] Webinar on September 12 - Qualification of Medical Device Development Tools
The U.S. Food and Drug Administration (FDA) is scheduled to hold a webinar on September 12, 2023. This webinar is intended for industry...
Provision Consulting Group
Sep 1, 20231 min read
![[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction](https://static.wixstatic.com/media/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg/v1/fill/w_1202,h_678,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg)
![[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction](https://static.wixstatic.com/media/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg/v1/fill/w_1202,h_678,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_858b7b33349c4557bd280b84c4732453~mv2.jpg)
[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction
After 84 years, the FDA Modernization of Cosmetics Regulation Act (MoCRA) is being revised and is set to take effect on December 29,...
Provision Consulting Group
Aug 14, 20233 min read
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