FDA News

Receiving an FDA warning letter can be a daunting experience for any business. This official notice signals significant violations that...

Imagine this: You’re in the middle of a busy workday, juggling emails and meetings, when suddenly, you get the call. The FDA is at your...

Today is Election Day and most of us are nervously biting our nails while awaiting the results. Some because it could affect their legal...

Starting your own small business can be hard work, but extremely rewarding. Add a major governmental agency like the FDA into the mix and...

The Woodlands, Texas, August 19, 2022 (GLOBE NEWSWIRE) – Heather M. Bustos, Esq., Partner at FDA compliance firm, Bustos Law Group, has...

Discovering a new ingredient for a dietary supplement can be exciting. Not only is there a possibility of the ingredient helping...

Guided by their scientific findings, the FDA has removed Hydroxychloroquine and Chloroquine from the FDA emergency authorization citing...

Today the Food and Drug Administration (FDA) released a list of 1,003 class II medical devices that it believes do not require premarket...

Earlier this month, on August 4th, the FDA issued Amazon a warning letter beginning, “ This letter concerns your firm’s distribution of...

Partner, Heather Bustos, Selected as 2022 Texas Rising Star by Super Lawyers. We are pleased to announce that our managing partner,...

If you are the parent of a newborn or infant in 2021, you most likely know about all the innovative new tech gadgets coming to market for...

A Note From Our Partner: Starting Bustos Law Group was always a dream of mine. I was fortunate enough to be introduced to the area of FDA...

The Food and Drug Administration (FDA) announced last week the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program...

In case you missed it, the FDA has now shifted course (as anticipated) and removed the availability of the EUA (Emergency Use...

The article titled: A COVID Success Story discusses the rise of Texas oil and gas companies moving into the hand sanitizer industry in...

The FDA has released a list of over 100 products that either contain methanol or have less than the required amount of ethyl or isopropyl...

During this pandemic, hand sanitizer has become vital. Household product to have “on hand” (excuse the pun). This has inspired many...

The FDA just removed 50 manufacturers from its PPE Emergency Use Authorization (EUA) out of fear that the masks do not meet the...

The internet is being bombarded with pictures of people in masks, people sewing masks out of fabric at home and some even making masks...

The FDA yesterday announced that it will not be taking action against manufacturers of hand sanitizer as long as they meet certain...