Mar 16 2022 The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go...

We want to give you some advice on Pre-Submission which leads to successful FDA approval. FDA offers a Pre-submission program and...

Mar 03 2022 We provide safety and regulatory information about soaps and lotions. Lotions, soaps, and other cleansers may be regulated as...

Mar 02 2022 The Food and Drug Administration (FDA) warns cosmetics companies when they make claims about their products that classify...

Feb 22 2022 FDA provides information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. These at-home COVID-19 diagnostic...

Feb 10 2022 Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in...

Feb 15 2022 FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product...

Feb 14 2022 The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of...

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....