People who are pregnant or breastfeeding often need to take prescription medications. Prescription-medication use during pregnancy and...

ISO 10993-10:2021 "Biological evaluation of medical devices - Part 10: Tests for skin sensitization" ISO 10993-10:2021 "Biological...

FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters As we have with...

The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying...

The U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12...

The U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older...

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech...

Provision Consulting Group ensures compliance with the US Food and Drug Administration (FDA) regulations through many years of experience...

Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery? Those are...

How to Study and Market Your Device Medical devices marketed in the United States are subject to the regulatory controls in the Federal...

The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of...

The U.S. Food and Drug Administration(FDA) announced the following actions taken in its ongoing response effort to the COVID-19 pandemic...

The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and...

Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some people. Many...

Immediately and thoroughly rinse eyes with gently running water if this occurs What safety concern is FDA announcing? The U.S. Food and...

Dental implants are medical devices surgically implanted into the jaw to restore a person's ability to chew or their appearance. They...

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of...

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19...

The following quote is attributed to Linda Katz, director of the FDA's Office of Cosmetics and Colors: “The FDA remains dedicated to...

The U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The...