Saturday, December 7, 2019

Saturday, December 7, 2019

Latest News

U.S. FDA: Statement on measuring the progress being made through implementing the FDA Food Safety Modernization Act

Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas, on measuring the progress being made through implementing the FDA Food Safety Modernization Act

LUMINEX: Receives FDA 510(k) Clearance for the ARIES® MRSA Assay

Luminex Corporation (NASDAQ: LMNX) announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES® MRSA Assay.

Acting FDA commissioner addresses vaping illnesses before the U.S. House Energy and Commerce Subcommittee

Acting Commissioner of the U.S. Food and Drug Administration (FDA) Norman E. ("Ned") Sharpless, M.D., has presented his remarks on the FDA’s planned regulation of electronic nicotine delivery systems (ENDS), including the investigation of vaping illnesses, before the U.S. House Energy and Commerce Subcommittee.

FDA issues Salmonella, Listeria warnings for Performance Dog frozen raw pet food

A Performance Dog frozen raw pet food sample has tested positive for Salmonella and Listeria monocytogenes (L. mono), causing the U.S. Food and Drug Administration (FDA) to issue a warning to pet owners.

FDA issued 19 warning letters to companies in September

The U.S. Food and Drug Administration issued 19 warning letters in September that were sent to manufacturers and other companies found to have violated FDA regulations.

CEPHEID: Receives FDA Clearance for Xpert® BCR-ABL Ultra Test

Enabling on-demand monitoring of BCR-ABL levels in patients with Chronic Myeloid Leukemia (CML)

DURECT: Announces FDA Advisory Committee Meeting to Review POSIMIR® for the Treatment of Post-Surgical Pain

DURECT Corporation (Nasdaq: DRRX) announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR® (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).

Pressure mounts on politicians, FDA to react to vaping-related illnesses, deaths

According to an article on the Forbes website, vaping will impact two sectors of the financial markets the most: Big Tobacco and marijuana stocks.

FDA unveils guidances for digital health care

The U.S. Food and Drug Administration (FDA) recently unveiled a series of guidances about utilizing digital health tools to help patients.

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.

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.

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.

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.

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.

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.

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 Reporter