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NEWS & BLOGS
Blog: Blog2
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[FDA Warning Letter Files] Your Product Could Be a Target, Too.
A Look at U.S. Market Regulations Through a Recent FDA Warning Letter “An FDA warning letter? That's only for big corporations, right?”...
Provision Consulting Group
Oct 83 min read
The $800 Magic Is Gone: Why Compliance is Now the Top Priority for U.S. Market Entry.
End of the De Minimis Rule: A New Barrier to U.S. Market Entry With the recent abolition of the de minimis rule, there has been a...
Provision Consulting Group
Sep 102 min read
Hotter Than the Sun: K-Beauty Sunscreens Face New Challenges in the U.S.
K-Beauty Sunscreens: Beloved by U.S. Consumers, Challenged by Tariffs and FDA Rules K-Beauty sunscreens are among the most popular Korean...
Provision Consulting Group
Sep 22 min read
FDA, New Medical Device User Fees for FY 2026
On July 30, 2025, the U.S. FDA announced the Medical Device User Fees applicable for Fiscal Year 2026 (October 1, 2025 – September 30,...
Provision Consulting Group
Aug 12 min read
New FDA Import Rules Eliminate $800 De Minimis Exemption
What the End of the “De Minimis” Rule Means for FDA-Regulated Imports As of July 2025, the U.S. FDA has officially eliminated the...
Provision Consulting Group
Jul 282 min read
Dexcom G7 15-Day Receives FDA Clearance: What This Means for Diabetes Management
April 14, 2025 The FDA has cleared the Dexcom G7 15-Day Continuous Glucose Monitoring (CGM) System, marking a significant milestone in...
Provision Consulting Group
Apr 142 min read
Why FDA New Drug Applications Are Expensive and Time-Consuming: Navigating the Long Road to Approval
October 16, 2024 When it comes to bringing a new drug to market, the hurdles of the FDA New Drug Application (NDA) process are immense....
Provision Consulting Group
Oct 16, 20243 min read
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