Feb 14 2022 02/11/2022, The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody...

Feb 10 2022 Generic drugs are copies that one company makes of a brand-name drug that was developed by another company. Generally,...

Feb 09 2022 When exporting medical devices to the US, what are the regulations? All medical devices imported into the United States...

Feb 07 2022 This section provides resources on regulatory requirements for cosmetic labeling. For a thorough explanation of cosmetic...

N95 respirators and surgical masks are examples of personal protective equipment that are used to protect the wearer from particles or...

FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types and...

Medical gloves are used by health care personnel to prevent the spread of infection or illness. Medical gloves are disposable and include...

What is a Medical Device Ban? A medical device ban is a total prohibition on the current and future sales, distribution, and...

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...