Facilities who have not complied with paying the annual OTC Monograph User Fee Program (OMUFA) fees required under section 744M of the...

As we reported in our previous blog post, the FDA is now collecting OTC Monograph User Fees beginning May 10, 2021. These fees will apply...

On March 27th, 2021, the FDA released the new OTC Monograph Facility Fees. New fees are due on May 10th, 2021.

Imagine an armband that, combined with special software, can tell you whether there is coagulation in the blood of a patient within 3-5...

"FDA has taken action to place all alcohol-based hand sanitizers from Mexico on import alert to help prevent entry of violative and...

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

There is a consensus that the Food and Drug Administration (FDA) is rushing the decision to “approve” Pfizers Covid-19 vaccine. Before...

The FDA has provided several updates regarding its ongoing response effort to the covid-19 pandemic. Included, was an update regarding...

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

The FDA's CDRH issued guidance, effective immediately, detailing new requirements for medical device manufacturers to notify it of shortages

Did your hand sanitizer come inside of a beer can? is it chocolate scented? FDA has begun receiving reports of hand sanitizers packaged...

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

On August 5th, our firm partner, Heather Bustos, spoke at a webinar hosted by the Houston Indonesian Consulate. She went through the...