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BIOGENNIX: Launches Agilon Bone Grafting Solution

By Press release submission | Sep 8, 2019

Applications for new drugs, biological products dip slightly in FY2019

By FDA Reporter Submission | Sep 5, 2019

U.S. FDA: Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations

By Press release submission | Sep 3, 2019

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SHINKEI THERAPEUTICS: FDA Accepts SHINKEI Therapeutics Investigational New Drug Application for MR-301 for Traumatic Brain Injury

By Press release submission | Aug 30, 2019

SHINKEI Therapeutics., a clinical stage pharmaceutical company focused on the development of therapeutic drugs for the treatment of Central Nervous System (CNS) disorders, today announced that they received notification from Food and Drug Administration (FDA), stating that FDA has accepted the filing of an Investigational New Drug (“IND”) application for MR-301 for the treatment of Severe Traumatic Brain Injury (sTBI) resulting in minimally conscious and/or vegetative comatose state.

Ningbo Huize Commodity receives FDA warning for quality control failures

By Keri Carbaugh | Aug 30, 2019

Ningbo Huize Commodity Company recently received a warning letter from the U.S. Food and Drug Administration over Current Good Manufacturing Practice (CGMP) violations.

New study says The Real Cost smoking prevention program saves 587,000 youths from smoking

By Keri Carbaugh | Aug 29, 2019

The Food and Drug Administration’s “The Real Cost” campaign prevents 587,000 youth from starting smoking and saves more than $53 billion, according to a new study in the American Journal of Preventive Medicine.

FDA issued 18 warning letters to companies in August

By FDA Reporter Submission | Aug 29, 2019

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

By Press release submission | Aug 26, 2019

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

By John Severance | Aug 24, 2019

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

By Press release submission | Aug 21, 2019

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

By Keri Carbaugh | Aug 16, 2019

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

By FDA Reporter Submission | Aug 14, 2019

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

By Sarah Downey | Aug 9, 2019

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

By FDA Reporter Submission | Aug 8, 2019

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

By Press release submission | Aug 8, 2019

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

U.S. FOOD AND DRUG ADMINISTRATION: FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities

By Press release submission | Aug 6, 2019

FDA statement on court ruling related to compounded bulk drug substances

FDA issued 14 warning letters to companies in July

By FDA Reporter Submission | Aug 2, 2019

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

By Keri Carbaugh | Aug 1, 2019

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

By Press release submission | Aug 1, 2019

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

By John Severance | Jul 31, 2019

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.

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1 FRESENIUS MEDICAL CARE: FDA Approves New Container System for Peritoneal Dialysis Solutions

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