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...

May 11 2022 The U.S. Food and Drug Administration(FDA) granted PMA(Premarket Approval) for OCS Heart System its donor hearts for...

05 05 2022 The U.S. Food and Drug Administration permitted marketing for the first in vitro diagnostic test for early detection of...

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

May 02 2022 The FDA is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the...

Apr 29 2022 FDA has approved Camzyos (mavacamten) capsules to treat adults with symptomatic New York Heart Association (NYHA)External...

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 27 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include...

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 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...

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 06 2022 On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis...

Apr 05 2022 Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion...

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 29 2022 The U.S. Food and Drug Administration(FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna...

Mar 28 2022 The U.S. Food and Drug Administration(FDA) issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding...