Tuesday, April 7, 2020

Tuesday, April 7, 2020

Latest News

FDA: Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

Transition is Expected to Increase Patient Access and Potentially Lower Prices on Insulin

FDA: Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail

MEDICREA: Announces FDA Clearance of the World’s First Patient-Matched Spinal Interbody Cages

MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services and technologies, announced today that it has received FDA-Clearance for UNiD® IB3D Patient-Matched interbody cages which completes its UNiD® ASI platform technology.

U.S. FDA: Statement on quality issues with certain Cardinal Health surgical gowns and packs

FDA working with manufacturer to assess scope of potential contamination risk, possible supply chain disruptions

U.S. FDA: Statement on National Academies of Sciences, Engineering, and Medicine report on framing opioid prescribing guidelines for acute pain

In August 2018, the U.S. Food and Drug Administration contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures.

FDA plans 24 public meetings in November

The U.S. Food and Drug Administration (FDA) has scheduled 24 public meetings, conferences and workshops for November, the agency reported.

Mylan recalls anxiety medication Alprazolam

Mylan Pharmaceuticals Inc. is carrying out a voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5 mg, due to the potential presence of a foreign substance.

BLUEWILLOW: Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company's next-generation anthrax vaccine candidate.

ALZHEIMER'S ASSOCIATION: Statement Biogen to Submit Aducanumab Results in Early Alzheimer's to U.S. FDA

On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose.

Physicians committee wants FDA to require breast cancer warnings on cheese products

The Physicians Committee for Responsible Medicine (PCRM) has filed a petition with the U.S. Food and Drug Administration (FDA) that would require a warning label on all dairy cheese products warning about the potential increased risks of developing breast cancer.

FDA Update: September inspection citations

The U.S. Food and Drug Administration (FDA) inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.

AMERICAN ASSOCIATION OF ORTHODONTISTS: California Passes Dental Law Regarding Self-Applied Orthodontic Treatments

On October 13, 2019, California Governor Gavin Newsom signed Assembly Bill 1519 into law, granting the California Dental Board continued authority to oversee and regulate dental services in the state.

FDA Update: September medical device recalls

Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration (FDA).

U.S. FDA: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

The U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid).

FDA Health News