Tuesday, February 25, 2020

Tuesday, February 25, 2020

Latest News

FDA issued 18 warning letters to companies in August

The U.S. Food and Drug Administration issued 18 warning letters in August that were sent to manufacturers and other companies found to have violated FDA regulations.

DISCGENICS: Receives FDA Fast Track Designation for Cell Therapy for Disc Degeneration

DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational cell therapy, IDCT, currently being evaluated in regulator-allowed clinical trials in the U.S. and Japan for the reduction in pain and disability associated with degenerative disc disease (DDD), a major cause of chronic low back pain.

FDA to unveil new warning labels for cigarettes

The U.S. Food and Drug Administration is planning on unveiling a new rule where they will implement new health warnings in regard to cigarette packages.

BIOELECTRONICS CORPORATION: Files FDA 510(k) Application for Musculoskeletal Pain Complaints; Clinical Data Demonstrates Superior Drug Free Pain Relief to Prescription Strength NSAID Drug

BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, is pleased to announce that it has filed a 510(k), Premarket Notification application with the U.S. Food and Drug Administration (FDA).

Some flavored e-liquid and hookah tobacco products to be removed

Warning letters were issued by the U.S. Food and Drug Administration to four companies who do not have the required marketing authorization for 44 flavors of e-liquid and hookah tobacco products.

FDA Update: electronic submissions statistics

Electronic regulatory submissions sent to the U.S. Food and Drug Administration have increased year-by-year since the electronic system was launched in 2009, the FDA reports.

FDA policymaker to keynote hemp business summit

Leading authorities on hemp are set to gather next week in Portland, Oregon, in anticipation of learning more about upcoming regulations to the industry.

FDA Update: Mammography Procedure Numbers

Mammograms per year in the nation numbered more than 39.5 million as of Aug. 1, the U.S. Food and Drug Administration reports.

NETFLEX: NextFlex’s Technology Hub Complies With FDA Standards for Manufacturing of Medical Devices

Adherence to FDA Quality Standards Will Boost Ability of Fabrication Facility to Produce Pilot-Scale Devices for NextFlex Members and Customers

FDA issued 14 warning letters to companies in July

The U.S. Food and Drug Administration issued 14 warning letters in July that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA releases final PMSR requirements for combination drugs

The Food and Drug Administration (FDA) recently released guidelines for safety reporting for combination products that clarify which companies and products must abide by the final rules on post-marketing safety reporting (PMSR) requirements and how exactly to do so.

MESA BIOTECH INC.: Mesa Biotech to Present Comparative Flu & RSV Detection Analysis with Other FDA-Cleared Molecular Assays at the AACC Annual Scientific Meeting Lecture Series

Mesa Biotech Inc. is a privately-held, molecular diagnostic company that has developed the Accula™ System, an affordable, sample-to-answer, CLIA-waived PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis

Republican senators introduce innovation-driven drug-treatment bill; brace for resistance from FDA

Two Republican senators recently introduced a bill they claim would combat U.S. drug shortages and drive down the prices of drugs and medical devices by allowing patients to select treatments approved in other countries.

FDA issued 34 warning letters to companies in June

The U.S. Food and Drug Administration issued 34 warning letters in June that were sent to manufacturers and other companies found to have violated FDA regulations.

WUXI APPTEC: WuXi STA Shanghai & Changzhou Facilities Pass U.S. FDA Inspections

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.

AVA president says parents should play of a role in banning sales of vape products to minors

The American Vaping Association says FDA fear-mongering on vaping products for minors could end up making the products more enticing.

FDA Reporter