Saturday, December 7, 2019

Saturday, December 7, 2019

Latest News

U.S. FDA: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods

U.S. FDA: Statement on new steps to advance innovation in medical device sterilization with ethylene oxide

At the U.S. Food and Drug Administration we continue to closely monitor the supply chain effects of closures and potential closures of specific large-scale sterilization facilities that use a gas called ethylene oxide to sterilize certain medical devices prior to their use.

IRRAS: Announces FDA Clearance of New 510(K) Filing to Expand the Time of Use of IRRAflow®

IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow.

ANABIOS: FDA Awards AnaBios Contract to Obtain Critical Translational Data from Ex Vivo Human Cardiac Platform

The U.S. Food and Drug Administration (FDA) has awarded AnaBios an exclusive Indefinite Delivery Indefinite Quantity (IDIQ) contract to employ adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function.

Proposed FDA vaping regulations are 'extensive, outdated,' AVA president says

Former U.S. Food and Drug Administration (FDA) commissioner David Kessler drew attention last week when he said he thought Juul and other popular vaping manufacturers would be forced to leave the market under proposed FDA rules.

CORREVIO: Announces FDA Advisory Committee Meeting to Review Brinavess™ for Recent Onset Atrial Fibrillation

Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) will hold a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting in connection with its review of the pending New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV).

FDA vaping regulations will hurt consumers, independents, CASAA says

As FDA deadlines approach for regulations on electronic tobacco products, observers say the industry is in for a period of change and consolidation.

FDA issued 13 warning letters in October

The U.S. Food and Drug Administration (FDA) issued 13 warning letters in October that were sent to manufacturers and other companies found to have violated FDA regulations.

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.

FDA Reporter