In the United States, sunscreens are regulated as OTC (Over-the-Counter) drugs , not cosmetics. This means they are subject to strict regulatory frameworks governing everything from ingredients and SPF testing to labeling and safety standards. Recent FDA announcements do not necessarily mean an immediate overhaul of all existing rules. Instead, they signal a strategic update to OTC Monograph M020 , clarifying the standards and direction for future sunscreen regulations. How i

How has the FDA cosmetic recall system evolved since MoCRA? In the past, even when issues arose with cosmetics sold in the U.S., they were primarily managed through voluntary recalls by companies. However, with the enactment of MoCRA  (Modernization of Cosmetics Regulation Act) in late 2022, the FDA’s legal authority to intervene in the cosmetics sector has become significantly clearer. Recently, the FDA released a Draft Guidance on Mandatory Cosmetics Recalls, outlining the

The way we live today is intrinsically tied to data. From the prescriptions we receive at the hospital and the glucose meters we use at home to the ECG features on our smartwatches and the records in our health apps—we are constantly generating a stream of "real-world data." Crucially, this data is now moving beyond simple record-keeping. Recent news indicates that this real-world data can serve as compelling evidence to support new product approvals (or regulatory reviews).

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

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...

The U.S. FDA recently launched a new online dashboard for tracking cosmetic product adverse events in real time. This is a significant...

On July 30, 2025, the U.S. FDA announced the Medical Device User Fees applicable for Fiscal Year 2026 (October 1, 2025 – September 30,...

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...

June 06, 2025 What You Need to Know As of early June 2025, the CDC and FDA confirmed a multi-state Salmonella Enteritidis outbreak...

Published June 06, 2025 Provision Consulting Group Introduction: In a significant move to modernize its internal operations, the U.S....

Published May 23, 2025 Provision Consulting Group A closer look at the FDA’s latest changes to COVID-19 vaccine approvals—and how they...

Published: May 16, 2025 Provision Consulting Group On May 9, 2025, the U.S. Food and Drug Administration (FDA) officially approved three...

May 14, 2025 Provision Consulting Group The U.S. Food and Drug Administration (FDA) has announced a 60-day extension to the public...

April 21, 2025 In the latest FDA acne product recall, certain acne treatments were pulled from the shelves after testing revealed benzene...

April 14, 2025 The FDA has cleared the Dexcom G7 15-Day Continuous Glucose Monitoring (CGM) System, marking a significant milestone in...

April 11, 2025 In recent news, the FDA issued a recall for coffee grounds sold in 15 states after the product was misbranded as...

April 09, 2025 In the world of medical device imports, understanding and complying with FDA regulations  is paramount. Recently,...

March 21, 2025 The U.S. Food and Drug Administration (FDA) has recently mandated a comprehensive return-to-office policy, requiring...

Friday, March 21, 2025 The U.S. Food and Drug Administration (FDA) recently issued a macaroni recall alert for 365 Whole Foods Market...

Monday, March 17, 2025 Introduction In the fast-paced world of medical technology, innovation often races ahead of regulation. Dexcom , a...