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Tag: FDA News

FDA Launches Unified Adverse Event Monitoring System (AEMS), Expanding Safety Surveillance and Regulatory Oversight

03/24/2026

On March 11, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of the Adverse Event Monitoring System (AEMS), a centralized, AI-driven platform that modernizes the agency’s post-market safety surveillance framework across all regulated product categories. These include medical products, vaccines, medical devices, tobacco products, food, cosmetics, and veterinary medicines. AEMS represents a […]

The Color of Compliance

02/24/2026

When Voluntary Isn’t Exactly Optional

If your company makes, markets, manufactures food, beverages, or supplements, you’ve likely noticed that color is having a moment. Under the MAHA banner, Robert F. Kennedy Jr. and the U.S. Food and Drug Administration have set their sights on “petroleum-based synthetic dyes.” Yes, the usual suspects remain perfectly lawful and fully approved for use. But […]

Love, Labels, and Selling Self-Care Without Selling an Unapproved Drug

02/10/2026

FDA’s Valentine’s Day Reminder for OTC Drug Claims

Valentine’s Day is peak season for self-care. Consumers are encouraged to love themselves a little harder, sleep a little better, feel a little calmer, and look a little brighter—preferably by picking something up from the drugstore endcap wrapped in pink and red packaging. For OTC drug manufacturers, however, February also brings a familiar reminder from […]

Preparing for FDA’s 2026 Human Foods Priorities: Transparency is the New Flavor

02/04/2026

What the Human Foods Agenda Means for Regulated Businesses

If you thought the FDA’s Human Foods Program (HFP) spent 2025 just rearranging labels and scolding salt shakers, think again. In 2026, the agency is showing up with a color-coded spreadsheet, a microscope, and a very strong opinion about what’s in America’s pantry. This is the year the FDA leans all the way into Making […]

FDA’s New Cosmetic Recall Power

01/20/2026

What Brands Need to Know Now

By all appearances, the FDA just decided to use one of MoCRA’s sharpest tools—and sooner than expected. On December 18, 2025, the U.S. Food and Drug Administration (FDA) quietly (but significantly) released a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” The document clarifies how the Agency intends to exercise […]

New Year, New Guidance

01/13/2026

FDA Recalibrates Its Approach to General Wellness Devices

As the calendar flips and the industry collectively resolves to innovate smarter, faster, and with fewer regulatory headaches, FDA has offered an early New Year’s surprise. The Center for Devices and Radiological Health (CDRH) has issued an updated version of its General Wellness: Policy for Low Risk Devices guidance—an update that meaningfully reshapes the regulatory […]

FDA’s Annual Device Registration Renewal Is Back Online — and the Clock Is Ticking to December 31

11/14/2025

(Yes, it’s that time of year again — compliance season!)

The Compliance Countdown Resumes After a brief, unplanned intermission caused by the recent U.S. government shutdown, the FDA’s Device Establishment Registration and Listing system is officially back online and operational. For medical device manufacturers, importers, and other regulated establishments, this means it’s time to get back to business — and more importantly, back to compliance. […]

A Fine Line Between SPF and Soufflé

11/04/2025

Format Risk in the Era of Foodified Beauty

The consumer-beauty/personal‐care sector is operating in what one might call a “regulatory + innovation squeeze”-zone. On one hand, major regulatory enforcement activity is underway — particularly from the FDA’s Center for Drug Evaluation and Research (CDER) — which signals heightened agency focus on non-traditional dosage forms, claims and cross-category blur. On the other hand, brand […]

Dashboard Confessional

09/29/2025

FDA Spills the Tea on Cosmetic Adverse Events

In a bold step toward greater public transparency, the U.S. Food and Drug Administration (FDA) has officially launched the FAERS Public Dashboard for Cosmetic Products. This new online tool provides real-time access to adverse event reports tied to cosmetic and personal care products, making it easier than ever for the public, regulators, and industry stakeholders […]

FDA Launches Nationalized Entry Review Program

09/04/2025

A Transformative Shift for Regulated Imports

As of August 4, 2025, the FDA’s Office of Import Operations (OIO) has launched the Nationalized Entry Review (NER) program, a new system that aims to standardize and improve the review of imported products. Revolutionizing how the agency reviews imports of FDA‑regulated products, the NER replaces the old port-by-port processing model with a centralized, technology […]

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