Tuesday, November 12, 2019

Tuesday, November 12, 2019

Latest News

FDA reports progress in support of opioid recovery and treatment act

The U.S. Food and Drug Administration's (FDA) acting commissioner, Dr. Ned Sharpless, has released a statement on the agency’s efforts to address the opioid crisis as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act marked its one year anniversary on Oct. 24.

CARSGEN: Announces Investigational CAR-T Therapy CT053 Granted RMAT Designation by the U.S. FDA for R/R Multiple Myeloma

ARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM).

GARWOOD MEDICAL DEVICES: FDA Grants Breakthrough Device Designation to BioPrax™ Biofilm Disruption Device

Garwood Medical Devices, a company focused on advancing infection control through innovation, announces today that it has been granted Breakthrough Device designation by the Food and Drug Administration (FDA) for its BioPrax™ device.

ORTHO CLINICAL DIAGNOSTICS: FDA Clears ORTHO™ Sera ID-MTS for Use on the ORTHO VISION® Analyzer

Fully Automated Technology from Ortho Clinical Diagnostics Aids in Extended Antigen Phenotyping and Ensures Delivery of Safe Blood to Transfusion Patients

Former FDA official responds – in part – to Taxpayers Protection Alliance's suggested reforms

Dr. David Gortler, former Food and Drug Administration (FDA) official, drug safety and FDA regulatory affairs expert and pharmacology professor, responds to the Taxpayers Protection Alliances’ (TPA) list of recommendations to improve business strategies released Oct. 3.

CARBOFIX: Extends Its CarboClear® Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System

The product to be officially launched during the Congress of Neurological Surgeons (CNS) in San Francisco, October 21-23, 2019

OSSDSIGN AB: Receives US FDA Clearance for Cranial PSI Accessories - Strengthening Business Position in the US

OssDsign AB (publ) ("OssDsign" or the "Company") today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) to market OssDsign Cranial PSI Accessories in the US.

ALLSCRIPTS: Veradigm Health joins Harvard Pilgrim to develop next phase of FDA’s Sentinel System

Five-year award signals FDA’s commitment to national program utilizing electronic healthcare data to monitor the safety of FDA-regulated drugs and other medical products

BECKMAN COULTER: DxA 5000 total laboratory automation solution receives U.S. FDA 510(k) clearance

Beckman Coulter, a global leader in clinical diagnostics, announced that the DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is now available for sale in the United States.

Taxpayers Protection Alliance recommends FDA reforms

The U.S. Food and Drug Administration (FDA) holds primary responsibility for approving and regulating various human and animal prescription drugs, medical and tobacco products and the nation’s food supply.

ABSORPTION SYSTEMS: Awarded 5-year IDIQ Contract by the U.S. Food and Drug Administration

To conduct preclinical testing of locally-acting topical dermal and ophthalmic drug product formulations

TECLENS: TECLens and SERVImed Industrial Spa Announce a Partnership to Pursue U.S. FDA Approval for Trans-epithelial Corneal Cross-Linking

TECLens, a medical device manufacturer and SERVImed Industrial Spa, an ophthalmic medical devices manufacturer and distributor today announced their partnership aimed at development and FDA approval of a new combination product to treat keratoconus.

TRINEtX: Named Technology Partner for FDA Sentinel System

TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), has been named a technology partner in two coordinating centers of the FDA's Sentinel System, a national program that uses electronic health care data to monitor the safety of FDA-regulated drugs and other medical products.

PROTOM: Receives U.S. FDA 510(k) Clearance for Its Radiance 330® Single Room Proton Therapy System

ProTom International Holding Corporation ("ProTom"), a market-leading proton therapy technology manufacturer, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its Radiance 330 proton therapy system installed at Massachusetts General Hospital ("MGH") in Boston, Massachusetts.

FDA Reporter