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).
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.
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
LENSAR® Laser System with Streamline® IV Capabilities Expands to Include Micro Radial Incisions, Allowing Surgeons to Treat Additional Corneal Conditions
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.
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.
Legislation that would allow terminally ill patients to access stem cell treatments not yet signed off by the U.S. Food and Drug Administration now is in the North Carolina state Senate after unanimously passing the House last week.
Vizient, Inc. today submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.
Whistleblowers are claiming that pharmaceutical companies are bribing doctors to sell their drugs so they can raise the prices on them.
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
The first generic version of Penicillamine Capsules USP is now approved in the U.S.
Regis Technologies, a contract development and manufacturing organization for small molecule active pharmaceutical ingredients, earned perfect results from its April 2019 FDA inspection.
The U.S. Food and Drug Administration approved 438 drug products in April, according to an online list the agency updated this week.
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.
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.
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.
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.
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.
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.
