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NEWS & BLOGS
Blog: Blog2
US Shutdown Ending Imminent: Now is the 'Golden Time' for FDA Renewal
Major foreign news outlets, including CNN, are reporting that the US federal government shutdown is finally nearing its end. While an official termination announcement has not yet been made, the normalization of government operations is imminent. Once federal agency operations resume, medical device registration and renewal processes, which had been suspended, will fully restart. This period is historically the time when system delays and errors are most frequent, as companie
Provision Consulting Group
Nov 122 min read
The FDA is Down: What the US Shutdown Means for Industry, and How to Respond
The recent failure of the U.S. federal government to reach a budget agreement has led to a government 'shutdown'. While we're used to...
Provision Consulting Group
Oct 103 min read
Beyond MoCRA: Using the FDA's New Dashboard to Build Trust and Brand Value.
The U.S. FDA recently launched a new online dashboard for tracking cosmetic product adverse events in real time. This is a significant...
Provision Consulting Group
Sep 153 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
Egg Recall Alert: Nearly 20 Million Eggs Recalled Amid CDC-Linked Salmonella Outbreak — What FDA-Regulated Businesses Must Know
June 06, 2025 What You Need to Know As of early June 2025, the CDC and FDA confirmed a multi-state Salmonella Enteritidis outbreak...
Provision Consulting Group
Jun 102 min read
FDA Introduces Elsa: A Generative AI Tool to Enhance Regulatory Efficiency
Published June 06, 2025 Provision Consulting Group Introduction: In a significant move to modernize its internal operations, the U.S....
Provision Consulting Group
Jun 62 min read
FDA COVID-19 Vaccine Policy Update: What It Means for You in 2025
Published May 23, 2025 Provision Consulting Group A closer look at the FDA’s latest changes to COVID-19 vaccine approvals—and how they...
Provision Consulting Group
May 233 min read
FDA Approves Three New Food Color Additives from Natural Sources
Published: May 16, 2025 Provision Consulting Group On May 9, 2025, the U.S. Food and Drug Administration (FDA) officially approved three...
Provision Consulting Group
May 162 min read
FDA Extends Comment Period for Proposed Front-of-Package Nutrition Labeling Rule
May 14, 2025 Provision Consulting Group The U.S. Food and Drug Administration (FDA) has announced a 60-day extension to the public...
Provision Consulting Group
May 142 min read
FDA Acne Product Recall: What Manufacturers Need to Know About Benzene Contamination
April 21, 2025 In the latest FDA acne product recall, certain acne treatments were pulled from the shelves after testing revealed benzene...
Provision Consulting Group
Apr 212 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
Don’t Let Mislabeling Cost You: What the FDA Coffee Recall Teaches Us About Compliance
April 11, 2025 In recent news, the FDA issued a recall for coffee grounds sold in 15 states after the product was misbranded as...
Provision Consulting Group
Apr 113 min read
Why Medical Device Importers Must Prioritize FDA Compliance: Lessons from a $550K Settlement
April 09, 2025 In the world of medical device imports, understanding and complying with FDA regulations is paramount. Recently,...
Provision Consulting Group
Apr 93 min read
FDA's Return-to-Office Challenges: Navigating Potential Delays in Regulatory Processes
March 21, 2025 The U.S. Food and Drug Administration (FDA) has recently mandated a comprehensive return-to-office policy, requiring...
Provision Consulting Group
Mar 212 min read
Undeclared Egg in Macaroni & Cheese Prompts FDA Recall Alert
Friday, March 21, 2025 The U.S. Food and Drug Administration (FDA) recently issued a macaroni recall alert for 365 Whole Foods Market...
Provision Consulting Group
Mar 212 min read
Dexcom’s Growth Surge Amid Regulatory Scrutiny: A Lesson in MedTech Resilience
Monday, March 17, 2025 Introduction In the fast-paced world of medical technology, innovation often races ahead of regulation. Dexcom , a...
Provision Consulting Group
Mar 172 min read
FDA’s GRAS Rule Reform: What It Means for Food Safety and Ingredient Transparency in 2025
March 12, 2025 In a significant shift aimed at bolstering food safety and consumer trust, U.S. Health and Human Services Secretary Robert...
Provision Consulting Group
Mar 123 min read
Food Additives Banned in Europe but Still Allowed in the U.S.: What Consumers Need to Know
March 10, 2025 When it comes to food safety, regulations can vary significantly between countries. While the European Union (EU) has...
Provision Consulting Group
Mar 102 min read
The FDA Bans Red No. 3 in Food and Drugs: What You Need to Know
March 04, 2025 The U.S. Food and Drug Administration (FDA ) has officially announced the revocation of Red No. 3 (FD&C Red No. 3) as a...
Provision Consulting Group
Mar 43 min read
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