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FDA conducts mass seizure of food and medical products held under insanitary conditions

The U.S. Food and Drug Administration today announced that, on behalf of the agency, the U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held under insanitary conditions in which they were exposed to widespread rodent, insect and live animal infestation.

12 Nov 2018

FDA announces emergency use authorization of Ebola fingerstick test with portable reader

Today, the U.S. Food and Drug Administration announced that an emergency use authorization has been issued for a rapid, single-use test for the detection of Ebola virus.

12 Nov 2018

Young men struggle much more with body image disorders than thought

Young men who are overly preoccupied with building muscle have a significantly higher risk of depression, weekend binge drinking, and dieting that is not connected to obesity.

9 Nov 2018

By-product of berry juice production could lower cancer risk

Group of scientists at Kaunas University of Technology, Lithuania are investigating the possibilities of using berry pomace to increase the safety of meat products and, probably, to mitigate their negative effects on human health.

7 Nov 2018

FDA and DOD sign MOU regarding medical product development and assessment

Today, the U.S. Food and Drug Administration and the Department of Defense's Office of Health Affairs signed a Memorandum of Understanding regarding medical product development and assessment.

5 Nov 2018

FDA authorizes two devices that provide real-time location of parathyroid tissue during surgery

Today, the U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands).

2 Nov 2018

Certain test strips used with home-use devices may provide inaccurate results, warns FDA

The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner, warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage.

2 Nov 2018

FDA permits marketing of 23andme Personal Genome Service Pharmacogenetic Reports test

Today, the U.S. Food and Drug Administration permitted marketing, with special controls, of the 23andme Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient's ability to metabolize some medications to help inform discussions with a health care provider.

1 Nov 2018

That’s a lot of scratch: The $48,329 allergy test

Janet Winston had a rash that wouldn't go away. The English professor from Eureka, Calif., always had been sensitive to ingredients in skin creams and cosmetics. This time, however, the antifungal cream she was prescribed to treat her persistent rash seemed to make things worse. Was she allergic to that, too?

29 Oct 2018

FDA authorizes marketing of PicoAMH Elisa test to help determine woman's menopausal status

Today, the U.S. Food and Drug Administration permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the determination of a patient's menopausal status.

25 Oct 2018

FDA approves new antiviral flu treatment

Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

24 Oct 2018

Federal court orders Tennessee-based company to stop selling OTC drug products

A federal court ordered a Tennessee-based company to stop selling over-the-counter (OTC) drug products until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements listed in a consent decree.

24 Oct 2018

FDA targets 465 websites that sell potentially dangerous, unapproved drugs

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers.

23 Oct 2018

Environment impact of microplastics remains unclear

Scientists say there is not yet enough evidence to conclude that microplastics do or do not cause harm to the environment, following a review of more than 300 global studies.

17 Oct 2018

FDA, DHS announce memorandum of agreement to address cybersecurity in medical devices

As part of the Administration's ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

17 Oct 2018

FDA approves novel molecular-based assay to help determine blood compatibility

The U.S. Food and Drug Administration today approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility.

11 Oct 2018

FDA approves expanded use of Gardasil 9 for adults aged 27 to 45 years

The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.

6 Oct 2018

FDA authorizes marketing of new Bose Hearing Aid

The U.S. Food and Drug Administration today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss).

5 Oct 2018

New method for quantification of liposome formulated drugs

Postnova Analytics has published an application study that describes a new method for quantification of liposome encapsulated drug using Centrifugal Field-Flow Fractionation

From Postnova Analytics 5 Oct 2018

FDA permits marketing of ClonoSEQ assay to detect minimal residual disease in blood cancer patients

Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing-based test for minimal residual disease in patients with acute lymphoblastic leukemiaor multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person's bone marrow.

30 Sep 2018