FDA OK'd 438 drugs in April
The U.S. Food and Drug Administration approved 438 drug products in April, according to an online list the agency updated this week.
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SAFETRACES, INC.: Granted U.S. Patent for Groundbreaking DNA-based Barcoding Technology to Improve Food Traceability with FDA approved DNA Tracers
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.
Relationship between doctors, drug companies questioned as debate continues over prices
As the matter of prescription drug prices continues to generate debate, and some federal government action, one consumer advocate is warning the Food and Drug Administration (FDA) has loosened rules over interactions between physicians and pharmaceutical companies.
U.S. FOOD AND DRUG ADMINISTRATION: Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market
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.
NUEROVIVE PHARMACEUTICAL: NeuroVive's IND for Clinical Development of NeuroSTAT Approved by FDA
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.
'Right to try' patients should not be charged for treatment, health-care policy adviser speaking as 'health care consumer' says
Terminally and chronically ill patients should not be charged for “right to try” treatments, a health-care policy adviser for an Illinois-based free-market think tank, speaking as “a health-care consumer,” said during a recent interview.
AMERICAN NATIONAL STANDARDS INSTITUTE: ANSI/ANAB Accredits Quality Certification Services to Certify Foreign Food Supplies under U.S. FDA-FSMA Program
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.
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AirXpanders® Announces Special 510(k) Submission to the US FDA for a Smooth Shell Version of the AeroForm® Tissue Expander System
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.
Citizens Commission on Human Rights International concerned over electrotherapy in children
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).
FDA looks to modernize on food safety
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.
HAEMONETICS CORPORATION: Receives FDA Clearance For Expanded Use Of TEG® 6s Hemostasis Analyzer System In Adult Trauma Settings
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.
ALLIANCE FOR SAFE BIOLOGIC MEDICINES: Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products
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.
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U.S. FOOD AND DRUG ADMINISTRATION: FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards
The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations.
Pharmacology professor, expert speaks out on FDA drug safety
David Gortler, a professor of pharmacology and a former FDA official, says the FDA needs to do more to ensure the quality of drugs delivered to the U.S. market, with particular concern given to generic drugs produced in “sweatshop” countries.
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ORSENSE LTD.: FDA Grants Market Clearance for the OrSense NBM200; the First Noninvasive Hemoglobin System Cleared for Use in Blood Donation Centers
OrSense Ltd., a leading developer of systems for non-invasive measurements of Hemoglobin, today announces that its NBM200 non-invasive Hemoglobin measurement device has received FDA/CBER 510(K) clearance for use in blood banks
IDLOGIQ INC: IDLogiq® Innovations Selected by FDA DSCSA Pilot Project Program to Address National Security of Drug Supply Chain
IDLogiq® innovations have been selected by the Food and Drug Administration (FDA) for the Pilot Project Program under the Drug Supply Chain Security Act (DSCSA) to prototype and develop a system that can address the national security of the drug supply chain and future interoperability of secure electronic information exchange.
AMDT HOLDINGS, INC.: Gains FDA Clearance for SixFix™ Hexapod Device
Innovative external fixator shortens surgical time, simplifies inventory, and enhances patient care.
New treatments for transthyretin mediated amyloidosis approved
Two new medicines, Vyndaqel and Vyndamax, were approved for adults by the Food and Drug Administration earlier this month. They will help to treat heart disease caused by transthyretin mediated amyloidosis (ATTR-CM).
First treatment approved for children with Lambert-Eaton myasthenic syndrome
Children aged 6-17 with the autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS) have the first treatment for their disease with the Food and Drug Administration-approved Ruzurgi.
Congress must consider legislation to allow fast track approval of drugs available in other developed countries: researcher
Congress should work on legislation allowing the FDA to fast-track the approval of some drugs already on the market in other developed countries, according to one researcher attached to a west coast free market think tank.