US physicians and patient advocacy organizations expressed their overwhelming support for the FDA's suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.
Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the medical indication of its TEG® 6s Hemostasis Analyzer System for use in adult trauma settings.
FDA acting commissioner Norman Sharpless and deputy commissioner for food policy and response Frank Yiannas released a statement on the changes technology has made on how Americans receive their food.
The Citizens Commission on Human Rights International (CCHR) raised concerns over the Food and Drug Administration approving the Monarch eTNS System for children 7-12 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
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AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, announced that the company has submitted a Special 510(k) pre-market notification to the US Food and Drug Administration (FDA) for a Smooth Shell version of the AeroForm Tissue Expander System.
The American National Standards Institute (ANSI), coordinator of the U.S. voluntary standardization system, has accredited Florida Certified Organic Growers, Inc. DBA Quality Certification Services in accordance with the international standard ISO/IEC 17065, Conformity assessment—Requirements for bodies certifying products, processes, and services; and pertinent certification scheme requirements and regulations under the U.S. Food & Drug Administration (FDA)'s Food Safety Modernization Act, or FSMA. ANSI's conformity assessment accreditation programs were reorganized in December 2018 under the ANSI National Accreditation Board(ANAB) brand, a wholly owned subsidiary of ANSI.
NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced that the US Food and Drug Administration, FDA, has approved NeuroVive's IND (Investigational New Drug) application, enabling clinical studies in the US with the company's drug candidate NeuroSTAT in development for treatment of moderate to severe traumatic brain injury, TBI.
The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics.
SafeTraces, Inc. announced that the U.S. Patent and Trademark Office granted the company a U.S. Patent titled DNA Based Bar Code for Improved Food Traceability.
Regis Technologies, a contract development and manufacturing organization for small molecule active pharmaceutical ingredients, earned perfect results from its April 2019 FDA inspection.
The first generic version of Penicillamine Capsules USP is now approved in the U.S.
Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women
Vizient, Inc. today submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.
OnKure, Inc., the epigenetics-focused drug discovery and development company that is advancing the first Largazole-derived, histone deacetylase inhibitor into Phase 1 clinical trials, announced that its lead drug, OKI-179, has cleared the FDA IND regulatory hurdle to start Phase 1 trials.
Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial.
LENSAR® Laser System with Streamline® IV Capabilities Expands to Include Micro Radial Incisions, Allowing Surgeons to Treat Additional Corneal Conditions
Hi-Tech Pharmaceuticals sued the FDA May 2nd, 2019 in Federal Court- Case 1:19-cv-01268, claiming the agency bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR).
The Regulatory Education for Industry Annual Conference will be held May 29-30 at the Revere Hotel, 200 Stuart St., Boston.
