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Electronic skin patch companies grapple with changing reimbursement schemes, report says

Ever-changing reimbursement schemes are forcing firms involved in electronic skin patches to lobby and adapt or leave the sector altogether, a research report surveying the product category said.

Cybersecurity issues lead to recall of some Medtronic insulin pumps

Medtronic MiniMed 508 and MiniMed Paradigm series insulin pumps are being recalled because of cybersecurity concerns, according to the Food and Drug Administration.

FDA warns of infection risk from fecal microbiota transplants

Patients who receive fecal microbiota for transplant (FMT) are at risk of life-threatening infections, the Food and Drug Administration said.

Life Rising’s dietary supplements seized over potential consumer risk

U.S. Marshals seized over 300,000 containers of Life Rising Corporation’s dietary supplements in a raid requested by the Food and Drug Administration.

Initial FDA tests find little fluoroalkyl compounds in foods

The FDA has been working on methods to determine how much per- and polyfluoroalkyl substances (PFAS) are in foods. Initial testing was done on foods common in the American diet.

FDA improving its regulation of cannabis products: Kline

The FDA is working toward better regulation of cannabis-based products, consulting services firm Kline said after a public hearing with the U.S. regulatory body.

ALS advocates considering ACT UP’s take-no-prisoners approach

Today, a group of ALS patients will come together to protest at the Food and Drug Administration building in Maryland to say they have not seen a response in research from the $115 million raised globally from the ice bucket challenge.

Device may offer relief to teens with irritable bowel syndrome

The IB-Stim would be used in combination with other IBS therapies.

Learning Tree International and Suntiva partner to support FDA Integrated Services BPA

A five-year base contract worth an estimated $100 million between Learning Tree International and Suntiva will help support the Food and Drug Administration (FDA) Integrated Services Blanket Purchase Agreement (BPA).

Curio Wellness wants cannabis to be regulated under Federal Food, Drug and Cosmetic Act

Curio Wellness, the market-leading medicinal cannabis company in Maryland, presented a scientifically grounded, patient-focused perspective to de-schedule cannabis and have it regulated under the Food and Drug Administration’s Federal Food, Drug, and Costmetic Act.

First test for Zika authorized by FDA

The ZIKV Detect 2.0 IgM Capture ELISA has been authorized for marketing by the Food and Drug Administration for detection of Zika virus immunoglobulin.

New blood thinner approved for pediatric patients

An anticoagulant injection, Fragmin, was approved by the Food and Drug Administration last week for pediatric patients.

FDA warns homeopathic manufacturers about false labeling

Five companies with products considered homeopathic have been found to be in violation of the FDA’s current good manufacturing practice regulations.

FDA asked to investigate JUUL’s claims of smoking cessation

The Food and Drug Administration has been asked to investigate the e-cigarette company JUUL and its claims that it helps people to stop smoking.

Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee to meet in June

A meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will take place on June 11 and June 12.

First treatment for all genotypes of hepatitis C in pediatric patients approved

Mavyret tablets were approved last week by the Food and Drug Administration for the treatment of all six genotypes of hepatitis C virus (HCV) in teenagers.

FDA moves to reduce risks associated with surgical staplers and implantable stables

The Medical Device Safety Action plan outlines the FDA’s mission to protect public health in a more timely and effective way.

New campaign seeks to remove opioids from the home

The Food and Drug Administration is looking to women aged 35-64 to “Remove the Risk” of opioids in the household.

Surgical mesh for transvaginal repair to be taken off the market

Manufactures of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) must stop selling their product after an order from the Food and Drug Administration.

FDA seeks public input on participation in rare-disease studies

The Food and Drug Administration is set to hold a public meeting on April 29 regarding “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.”

FDA Health News