Monday, March 30, 2020

Monday, March 30, 2020

Latest News

FDA: Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health

U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products.

FDA: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration.

FDA: Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic

Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).

OREXO: Submits Application for vorvida® to the FDA to Enable Commercialization in the US

*vorvida® clearance from FDA anticipated Q2 2020. Expects to launch its first digital therapy in the US for heavy alcohol use in H2 2020

MAGNOLIA MEDICAL: Receives FDA 510K Clearance for Expanded Steripath Gen2 Product Family

Products become the first and only indicated to reduce blood culture contamination

AACC: As U.S. Struggles to Get Coronavirus Testing Up and Running, AACC Calls on FDA to Allow Clinical Labs to Develop Their Own Tests for the Virus

In a letter to the Food and Drug Administration (FDA), AACC is urging the agency to allow clinical laboratories to develop coronavirus tests without going through FDA review.

FDA: Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries

LPMs are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site.

FDA: Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome

The U.S. Food and Drug Administration today authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability.

FDA: Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications

Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person will respond to specific medications.

CARELIGHT: Introduces Line Of FDA-Cleared Light Therapy Devices; Recognized Industry Leader Joins Sales Team

CareLight Solutions is proud to now be offering a complete line of industry-leading Light Therapy products to the public. Inspired by Nobel Prize-winning science, Light Therapy devices are backed by years of scientific research and are FDA-cleared to reduce pain and increase circulation.

CARDIOFOCUS: Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System

CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib.

U.S. FDA: FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans

The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products.

BIOHAVEN PHARMACEUTICALS: Biohaven's Verdiperstat Receives FDA May Proceed Letter To Initiate Trial In Amyotrophic Lateral Sclerosis Conducted By The Healey Center For ALS At Mass General

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a biopharmaceutical company with multiple late-stage neuroscience drug candidates in development, announced today that the U.S. Food and Drug Administration (FDA) has notified its collaborators at the Sean M. Healey & AMG Center for Amyotrophic Lateral Sclerosis (ALS) at Massachusetts General Hospital (MGH) that they may proceed with clinical investigation of verdiperstat, Biohaven's novel myeloperoxidase (MPO) inhibitor, in ALS.

THE FCS FOUNDATION: Familial Chylomicronemia Syndrome Foundation Commends FDA Decision to Create New Advisory Group to Support Rare Disease Drug Review Processes

Action aligns with requests from FCS Foundation for FDA to be more flexible and hear the patient voice when considering review of drugs to treat FCS

FDA Reporter