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NEWS & BLOGS
Blog: Blog2


2025 FDA Compliance Essentials for K-Beauty Brands
November 4, 2024 Introduction As K-beauty brands continue to gain popularity in the U.S., navigating FDA regulations is crucial for...
Provision Consulting Group
Nov 4, 20243 min read
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FDA Issues New 2024 Tattoo Ink Safety Guidelines: What Tattoo Artists and Consumers Need to Know
October 30, 2024 Introduction The tattoo industry has recently received a major update from the U.S. Food and Drug Administration (FDA)...
Provision Consulting Group
Oct 30, 20242 min read
168


How to Determine Your Product’s FDA Category: Is It a Cosmetic, Dietary Supplement, OTC Drug, or Medical Device?
October 18, 2024 When bringing a product to market, one of the most important steps is figuring out how the FDA categorizes your product...
Provision Consulting Group
Oct 18, 20244 min read
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Why K-Beauty’s Popular Ingredients Face Scrutiny from the FDA
October 02, 2024 K-beauty is renowned for its use of innovative and unique ingredients like snail mucin, ginseng, and centella asiatica,...
Provision Consulting Group
Oct 2, 20243 min read
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Navigating FDA Regulations: What K-Beauty Brands Need to Know to Enter the U.S. Market
September 27, 2024 The global rise of K-beauty is undeniable, with its innovative products and unique skincare routines taking over...
Provision Consulting Group
Sep 27, 20243 min read
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K-Beauty Sunscreens and the FDA: How Regulatory Differences Affect U.S. Consumers
September 30, 2024 K-beauty sunscreens have gained massive popularity in recent years, often praised for their lightweight formulations...
Provision Consulting Group
Sep 27, 20243 min read
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![[FDA Regulation] Get Ready for the New FDA Medical Device CGMP Rule: A Glimpse of Final Rule](https://static.wixstatic.com/media/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.jpg/v1/fill/w_416,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.webp)
![[FDA Regulation] Get Ready for the New FDA Medical Device CGMP Rule: A Glimpse of Final Rule](https://static.wixstatic.com/media/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.jpg/v1/fill/w_454,h_273,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_0905ef2660dd4360800a728828ee5de6~mv2.webp)
[FDA Regulation] Get Ready for the New FDA Medical Device CGMP Rule: A Glimpse of Final Rule
Date: 1/31/2024 The Food and Drug Administration (FDA) has announced the issuance of a device final rule aimed at amending the current...
Provision Consulting Group
Jan 31, 20242 min read
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FDA’s MoCRA Cosmetics Portal is Open: A Game-Changer for Industry Compliance
Date: 12/19/2023 FDA’s MoCRA Cosmetics Portal is Open! Cosmetics Constituent Update: December 18, 2023 In a significant move, the U.S....
Provision Consulting Group
Dec 19, 20232 min read
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Unveiling the Dynamics in the Cosmetics Industry Extended MoCRA Implementation and Registration
Date: 12/13/2023 The Dynamics of the Cosmetics Industry in Response to the Extension of MoCRA Facility and Product Registration Deadlines...
Provision Consulting Group
Dec 13, 20233 min read
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Daewon Pharmaceutical Co., Ltd. Preparing for FDA Quality Management System (QMS) and cGMP Inspection with Provision Consulting Group
Date: 12/11/2023 Daewon Pharmaceutical Co., Ltd. Preparing for FDA Quality Management System (QMS) and cGMP Inspection with Provision...
Provision Consulting Group
Dec 11, 20232 min read
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Essential Cosmetic Testing for Entry into the U.S. Market
Date: 12/6/2023 In the glamorous world of beauty and skincare, cosmetics play a pivotal role, gracing our skin with radiance. However,...
Provision Consulting Group
Dec 6, 20232 min read
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Charting Corporate Success: Attaining Asia's Premier 510(k) Certification with Provision
Date: 11/27/2023 Empowering Women's Health Globally: Provision Consulting Group's Vital Role A pioneering force in women's products, our...
Provision Consulting Group
Nov 27, 20232 min read
9


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...
Provision Consulting Group
Nov 22, 20232 min read
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FDA Compliance & Amazon Success: Our Case Study in Rapid Regulatory Remediation
Date: 11/21/2023 Ensuring FDA Compliance and Resuming Sales: Provision Consulting Group's Expertise in Action in Amazon. Operating under...
Provision Consulting Group
Nov 21, 20232 min read
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Acquisition of 510(k) Certification: Ensuring Optimal Efficiency - Dental Implant Excellence
Date: 11/17/2023 Supported by the expertise of Provision Consulting Group, a leading global dental implant enterprise swiftly secured...
Provision Consulting Group
Nov 17, 20231 min read
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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
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![[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_375,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.webp)
![[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_454,h_303,fp_0.50_0.50,q_90,enc_avif,quality_auto/22ea40_35fa4598ad6a47779363956b8e23a647~mv2.webp)
[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
14


Provision Consulting Group traveled for FDA GMP/QMS Mock audit in South Korea
In March, 2023, Mr. Kwon, one of the Co-CEOs of Provision Consulting Group, traveled to South Korea to provide consulting services and...
Provision Consulting Group
Apr 13, 20231 min read
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