Jun 14 2022 The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go...

Jun 13 2022 When developing a new home use device, you should take the considerations in this FDA guidance into account and, to the...

Jun 10 2022 Aesthetic (cosmetic) devices are typically used to improve appearance. They may be regulated by FDA depending upon their...

Jun 06, 2022 The United States Food and Drug Administration develops and administers regulations under authority granted by laws passed...

Jun 03 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...

Jun 01 2022 For the manufacturers which Develop a new home-use device, we provide this guidance, and it applies to both prescription and...

May 23 2022 The U.S. Food and Drug Administration (FDA) recognizes these risks and strictly regulates design control requirements to...

May 13 2022 Most of the products on the market show a mark or ads that they have been approved by the FDA. And many companies say their...

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...