Apr 28 2022 In the medical device industry, time is the most important thing to your device market in the United States after innovation....

Apr 28 2022 At-home COVID-19 tests safety FDA authorized at-home COVID-19 tests are safe to use when people follow the manufacturer’s...

Apr 20 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words, these...

Apr 19 2022 FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing...

Apr 12 2022 In the United States, successfully launching a product is as important as developing a new medical device. Let's take a look...

Apr 08 2022 Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 This table includes information about authorized SARS-CoV-2...

Apr 04 2022 On April 19, 2022, the United States Food and Drug Administration(FDA) will provide a virtual MDUFA V public meeting that is...

Mar 29 2022 Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some...

Mar 25 2022 FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (guidance...

Mar 23 2022 The U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions...

Mar 21 2022 On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP)...

Mar 17 2022 FDA requires a generic drug company to produce enough data to demonstrate the company can make a drug that can be...

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...