FDA issued 18 warning letters to companies in August
The U.S. Food and Drug Administration issued 18 warning letters in August that were sent to manufacturers and other companies found to have violated FDA regulations.
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CONCEPT MEDICAL INC.: Granted 'Breakthrough Device Designation' From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure.
AVRA MEDICAL ROBOTICS: Initiates Food and Drug Administration Approval Process
AVRA Medical Robotics, Inc. (the “Company”) (OTCQB: AVMR), an emerging growth company that is in the process of building a fully autonomous medical robotic system through the use of new technologies combining artificial intelligence, machine learning and proprietary software; announced that its regulatory and management teams met with the Food and Drug Administration (FDA) on August 12th.
New study says The Real Cost smoking prevention program saves 587,000 youths from smoking
The Food and Drug Administration’s “The Real Cost” campaign prevents 587,000 youth from starting smoking and saves more than $53 billion, according to a new study in the American Journal of Preventive Medicine.
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Ningbo Huize Commodity receives FDA warning for quality control failures
Ningbo Huize Commodity Company recently received a warning letter from the U.S. Food and Drug Administration over Current Good Manufacturing Practice (CGMP) violations.
Taxpayer Protection Alliance: Get behind gene therapy revolution
For millions of people who suffer from debilitating diseases, experimental gene therapies hold much promise.
KAROLINSKA DEVELOPMENT AB: Karolinska Development's portfolio company Promimic receives FDA approval for its HAnano Surface® on a spinal implant
Karolinska Development's portfolio company Promimic today announced that the company’s first spinal device utilizing HAnano Surface to improve osseointegration has now been 510(k) approved by the FDA.
SHINKEI THERAPEUTICS: FDA Accepts SHINKEI Therapeutics Investigational New Drug Application for MR-301 for Traumatic Brain Injury
SHINKEI Therapeutics., a clinical stage pharmaceutical company focused on the development of therapeutic drugs for the treatment of Central Nervous System (CNS) disorders, today announced that they received notification from Food and Drug Administration (FDA), stating that FDA has accepted the filing of an Investigational New Drug (“IND”) application for MR-301 for the treatment of Severe Traumatic Brain Injury (sTBI) resulting in minimally conscious and/or vegetative comatose state.