FDA News Update

Triton MDOs Overturned

In a much-anticipated ruling, a federal appeals court has finally overturned the Marketing Denial Orders (MDOs) handed down to Triton Distribution and Vapetasia. The court…

Read More

FDA-CBP Joint Operation Seizes $18 Million Worth of Illegal E-Cigarettes, Targets Brands Popular Among Youth

In a significant joint effort, the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) have successfully seized over $18 million…

Read More

eSTAR Medical Device Submissions

The eSTAR (Electronic Submission Template and Resource) is an interactive PDF form designed to assist applicants in preparing comprehensive medical device submissions. It offers various…

Read More

FDA Targets Delta 8 Products

The Federal Trade Commission (FTC) has partnered with the U.S. Food and Drug Administration (FDA) to send cease and desist letters to six companies selling…

Read More

Submission Tracking Number

A Submission Tracking Number or STN is becoming a critical part of successfully importing tobacco products, such as vape devices. An STN can serve as…

Read More

FDA CBD Update

The US Food and Drug Administration has announced a new regulatory pathway is needed to manage risks from a growing cannabidiol (CBD) market in the US. FDA…

Read More

Modernization of Cosmetics Regulation Act of 2022

It appears Congress will pass the first major overhaul of cosmetics regulation in 84 years, giving more authority over the market to the FDA. Congressional…

Read More

Synthetic Nicotine Loophole Getting Shut Down By Congress

Congress will close the synthetic nicotine loophole this week when it passes an omnibus spending bill. What Is in the Current Bill? Subtitle B of…

Read More

Why was created the Remote Regulatory Assessments (RRA)?

Remote Regulatory Assessments A Remote Regulatory Assessment is a necessity created by the COVID-19 pandemic. Ordinarily, FDA would conduct an on-site audit as part of…

Read More

Is the Premarket Tobacco Product Applications (PMTAs) stagnated?

Over the past few weeks, I have continued to hear and receive questions regarding whether the Biden administration has frozen the PMTA process or rule. The short answer is no….

Read More

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars Back in December of 2020, then-president Trump signed into law the “Consolidated Appropriations Act,…

Read More

Microneedling FDA Clearance

Microneedling FDA Clearance has been granted to Esthetic Education LLC for its SkinStylus SteriLock MicroSystem (K200044). Esthetic Education is among the very first microneedling 510(k)…

Read More