Sunday, October 20, 2019

Sunday, October 20, 2019

Latest News

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.

FDA Update: 2019 animal product recalls

The U.S. Food and Drug Administration recalled 28 animal products from January through September of 2019, the agency reported.

MD Anderson's Hahn a frontrunner for FDA Commissioner

Stephen Hahn, M.D., Chief Medical Executive of The University of Texas MD Anderson Cancer Center, is the top candidate to be the next commissioner of the U.S. Food and Drug Administration (FDA).

Sen. Blumenthal calls on FDA to issue regulatory framework for CBD

U.S. Sen. Richard Blumenthal (D-CT) recently held a press conference in which he pleaded with the U.S. Food and Drug Administration (FDA) to establish a regulatory framework for the safe use of CBD.

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.

THINK SURGICAL: Receives FDA Clearance to Market Active Robot for Total Knee Replacement Procedures in the United States

Approval follows multi-center investigational clinical trial evaluating safety and efficacy of TSolution One® Total Knee Application

FDA Update: recent animal drug approvals

Federal law dictates that drug companies can’t manufacture and market medicines for animals unless they get the approval of the U.S. Food and Drug Administration.

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

FDA awards $15 million grant to 12 new clinical trials for rare-disease treatments

Over the next four years, the U.S. Food and Drug Administration (FDA) will be providing more than $15 million to 12 new clinical trials. The grants will help enhance the development of medical products for patients with rare diseases – mainly those affecting children.

FDA awards more than $4.1 million for natural history studies of rare diseases

The U.S. Food and Drug Administration (FDA) is providing more than $4.1 million in the next four years to fund two natural history studies of rare diseases.

INTARCIA THERAPEUTICS: Provides Regulatory Update - FDA Accepts Resubmitted New Drug Application For ITCA 650

Intarcia Therapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its new drug application (NDA) for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes mellitus. Intarcia resubmitted the NDA on September 9th, 2019 and the FDA has recently communicated that it considers the NDA resubmission a complete class 2 response, setting the Prescription Drug User Fee Act (PDUFA) target action date of March 9, 2020.

SEKISUI DIAGNOSTICS: Announces FDA Clearance and CLIA Waiver of the Acucy™ Influenza A&B Test

Sekisui Diagnostics announces the Acucy Influenza A&B Test has received 510(k) clearance as a Class II assay from the US Food and Drug Administration (FDA), as well as, CLIA Waiver (Clinical Laboratory Improvement Amendments) for use on the Acucy Reader.

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