Thursday, April 9, 2020

Thursday, April 9, 2020

Latest News

PUROLITE: Protein A Chromatography Resin Implemented Into FDA-approved Commercial Manufacturing of Monoclonal Antibody Treatments

Purolite Ltd., a leading manufacturer of resin-based separation, purification and extraction technologies, today announces that Praesto® Jetted A50, an agarose-based Protein A chromatography resin, has been incorporated into the commercial manufacturing process of an FDA-approved monoclonal antibody treatment by one of the world's leading contract manufacturing organizations.

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

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

FDA: Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity

Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.

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

NOVADOZ PHARMACEUTICALS: Increases Presence in the Generic Oncology Market with an FDA Approval of Thiotepa 15mg &100mg Vials for Injection

Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.

Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.

FDA: Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections

Today, we are providing an update on the status of U.S. Food and Drug Administration inspections outside of the U.S. in response to the COVID-19 outbreak.

FDA Launches New Campaign to Help Consumers Use the New Nutrition Facts Label

The U.S. Food and Drug Administration today launched an initiative to help consumers use the new Nutrition Facts label that appears on packaged foods to maintain healthy dietary practices.

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).

FDA: Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics

As part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.

FDA: Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements

U.S. Food and Drug Administration took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.

ABBOTT: Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

The test will be used on the company's m2000 RealTime system that is currently available in hospitals and molecular laboratories in the U.S.

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: Blood Donations

The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year.

FDA: Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.

BIOSTAGE: Announces IND Approval from FDA for its Lead Product Candidate Cellspan™ Esophageal Implant

Biostage, Inc. (OTCQB: BSTG) (Biostage or the Company), a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug application (IND) for the Cellspan Esophageal Implant (CEI) to treat patients with end-stage esophageal disease that require a segmental surgical resection to repair the diseased tissue.

FDA Reporter