Tuesday, February 25, 2020

Tuesday, February 25, 2020

Latest News

Sterilization facility closures may threaten availability of medical devices, FDA cautions

Acting commissioner of the U.S. Food and Drug Administration (FDA) Dr. Ned Sharpless recently released a statement regarding medical device availability following the closure of multiple sterilization facilities.

BLUEPRINT MEDICINES: Announces FDA Intent to Split Avapritinib New Drug Application into Separate Submissions for PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

Given proximity of NDA action date to anticipated top-line data readout for Phase 3 VOYAGER trial, FDA requested VOYAGER top-line data to inform its review of fourth-line GIST indicatio

FDA needs more oversight of regenerative medicine, Penn professor says

For nearly 20 years, regenerative medicine such as cell and gene therapies have gradually shown much promise in repairing or replacing damaged and infected cells, tissues and organs in order to cure ailments including organ failure, spinal cord injuries, multiple sclerosis and other traumatic wounds and diseases.

Johnson & Johnson announces recall after FDA test confirms asbestos in batch of baby powder

Legal teams pursuing numerous lawsuits against Johnson & Johnson on behalf of ovarian cancer victims alleging that asbestos in the manufacturer's baby powder made them sick are saying that J&J's announcement Friday of a voluntary recall of the product should help prove their claims.

MICROPHYT: Microphyt’s PhaeoSOL Receives New Dietary Ingredient (NDI) Status from the FDA

PhaeoSOL is a natural microalgae-based nutritional ingredient aiming at improving the well-being of the elderly and preventing certain metabolic disorders

FDA Update: 2019 animal product recalls

The U.S. Food and Drug Administration recalled 28 animal products from January through September of 2019, the agency reported.

FIDMI MEDICAL: Receives FDA Regulatory Clearance for Low-profile Enteral Feeding Device

Fidmi Medical Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it received 510K regulatory clearance from the United States Food and Drug Administration (FDA) for its low-profile enteral feeding device.

Sen. Blumenthal calls on FDA to issue regulatory framework for CBD

U.S. Sen. Richard Blumenthal (D-CT) recently held a press conference in which he pleaded with the U.S. Food and Drug Administration (FDA) to establish a regulatory framework for the safe use of CBD.

FDA awards $15 million grant to 12 new clinical trials for rare-disease treatments

Over the next four years, the U.S. Food and Drug Administration (FDA) will be providing more than $15 million to 12 new clinical trials. The grants will help enhance the development of medical products for patients with rare diseases – mainly those affecting children.

FDA unveils guidances for digital health care

The U.S. Food and Drug Administration (FDA) recently unveiled a series of guidances about utilizing digital health tools to help patients.

Pressure mounts on politicians, FDA to react to vaping-related illnesses, deaths

According to an article on the Forbes website, vaping will impact two sectors of the financial markets the most: Big Tobacco and marijuana stocks.

FDA issued 19 warning letters to companies in September

The U.S. Food and Drug Administration issued 19 warning letters in September that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA issues Salmonella, Listeria warnings for Performance Dog frozen raw pet food

A Performance Dog frozen raw pet food sample has tested positive for Salmonella and Listeria monocytogenes (L. mono), causing the U.S. Food and Drug Administration (FDA) to issue a warning to pet owners.

Acting FDA commissioner addresses vaping illnesses before the U.S. House Energy and Commerce Subcommittee

Acting Commissioner of the U.S. Food and Drug Administration (FDA) Norman E. ("Ned") Sharpless, M.D., has presented his remarks on the FDA’s planned regulation of electronic nicotine delivery systems (ENDS), including the investigation of vaping illnesses, before the U.S. House Energy and Commerce Subcommittee.

FDA Reporter