Tuesday, December 10, 2019

Tuesday, December 10, 2019

Latest News

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).

Washington Policy Center analyst says black-market THC products to blame for vaping deaths, illnesses

As Congress criticizes the Food and Drug Administration (FDA) for its 2017 delay of reviewing e-cigarettes and vaping products, and blames the agency for the current vaping-illness outbreak across the U.S., Washington Policy Center Health Care Policy Analyst Roger Stark, M.D., is stressing to the nation that the FDA should not be held responsible for the recent surge in health emergencies.

AMERICA'S BLOOD CENTERS: Urges FDA to Continue to Evaluate Impact of New Final Guidance on Platelet Availability

America's Blood Centers (ABC) encourages the Food and Drug Administration (FDA) to continue to assess the impact of the Final Guidance issued on Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Guidance for Industry.

FDA plans 19 public meetings in October

Nineteen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for October, the FDA reported.

Expanded recall set for blood pressure medication Losartan

Torrent Pharmaceuticals recently announced it was expanding its recall for Losartan potassium tablets and Losartan potassium/hydrochlorothiazide tablets.

Torrent's recall of drug to treat hypertension expanded

The recall of medications manufactured by Torrent Pharmaceuticals Ltd. to treat high blood pressure conditions has been expanded, the U.S. Food and Drug Administration reported.

British American Tobacco supports FDA's anti-vaping efforts

British American Tobacco CEO Kingsley Wheaton recently released a statement addressing the U.S. Food and Drug Administration’s work to prevent minors from vaping.

FDA Update: August inspection citations

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

FDA confirms guidance on placebos, blinding for cancer trials

The Food and Drug Administration (FDA) made a recommendation to drugmakers last week stating that they only use placebos in cancer clinical trials in select circumstances.

FDA Health News