Color additives are subject to a strict system of approval under U.S. law [Federal Food, Drug, and Cosmetic Act (FD&C Act), sec. 721; 21...

Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to...

1. What is an Over-the-Counter (OTC) Drug Product? An OTC drug product is a drug product marketed for use by the consumer without the...

Choosing Your COVID-19 Booster Shot Three COVID-19 vaccines are authorized or approved for use in the United States to prevent COVID-19....

Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the...

On December 15, 2021, FDA offered a webinar for OTC Sunscreen and discussed Deemed Final Order(DFO) for OTC sunscreen drugs. Active...

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and...

It is important to use nail products safely, following labeled directions and paying attention to any warning statements. The following...

By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs The U.S. Food and Drug Administration’s response to the COVID-19 pandemic...

Date: December 15, 2021 Time: 3:00 PM - 4:00 PM ET ABOUT THIS WEBINAR On September 24, 2021, FDA took steps aimed at improving the...

Check out the FDA's tips to safely use dermal fillers and learn the difference between dermal fillers and injectable botulinum toxin...

The U.S. Food and Drug Administration wants consumers to know certain “wellness” vaping products containing vitamins and/or essential...

The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course...

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...

Updated: 4/15/2024 Introduction Provision Consulting Group ("PCG") ensures compliance with the US Food and Drug Administration ("FDA")...

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...