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FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices

Provision Consulting Group

Sep 113 min read

FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices

Today, the U.S. Food and Drug Administration issued warning letters to two Chinese nonclinical testing laboratories, citing both for...

Understanding MoCRA Serious Adverse Event Reporting

Provision Consulting Group

Aug 282 min read

Understanding MoCRA Serious Adverse Event Reporting

Under the Modernization of Cosmetics Regulation Act (MoCRA), cosmetics companies selling in the US now face a new requirement: serious...

Challenges for Korean Sunscreen Exports Amid FDA Regulatory Tightening

Provision Consulting Group

Aug 203 min read

Challenges for Korean Sunscreen Exports Amid FDA Regulatory Tightening

The barriers to exporting Korean sunscreens to the U.S. have significantly increased. Although there have been reports of strong sales in...

Streamline Your Product Registration with UL WERCSmart®

Provision Consulting Group

Aug 142 min read

Streamline Your Product Registration with UL WERCSmart®

In today's competitive market, getting your products to market quickly and efficiently is essential. But navigating the complexities of...

FY2025 Medical Device User Fee Amendments (MDUFA) Has Been Announced

Provision Consulting Group

Aug 51 min read

FY2025 Medical Device User Fee Amendments (MDUFA) Has Been Announced

The FDA has released the updated Medical Device User Fee Amendments (MDUFA) for Fiscal Year 2025, which spans from October 1, 2024, to...

The US Color Cosmetics Market: K-Beauty Leads Growth

Provision Consulting Group

Jul 292 min read

The US Color Cosmetics Market: K-Beauty Leads Growth

Last year, the US color cosmetics market saw a 9.1% growth, driven by the success of Korean lip makeup products. Notably, the strong...

2024 Cosmoprof North America Las Vegas: Theft of Korean Pavilion Exhibits

Provision Consulting Group

Jul 242 min read

2024 Cosmoprof North America Las Vegas: Theft of Korean Pavilion Exhibits

Just one day before the opening of the '2024 Cosmoprof North America Las Vegas' (July 23-25, local time), all the items to be displayed...

First Warning Letter Mentioning MoCRA Has Been Issued

Provision Consulting Group

Jul 222 min read

First Warning Letter Mentioning MoCRA Has Been Issued

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 represents a significant shift in how cosmetics are regulated in the United...

Provision Consulting Group

Jul 182 min read

FDA Cracks Down on MoCRA Compliance

FDA recently began to crack down on compliance with the recently passed MoCRA (Modernization of Cosmetic Regulation Act) on cosmetic...

FDA Empowers Companies to Address the Spread of Misinformation About Medical Devices and Prescription Drugs

Provision Consulting Group

Jul 102 min read

FDA Empowers Companies to Address the Spread of Misinformation About Medical Devices and Prescription Drugs

The FDA is advancing its mission to ensure the public has access to accurate, science-based information about medical products. Updated...

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