FDA to host hearing on cannabis products
The FDA will have a hearing on scientific data and information about products containing cannabis or cannabis-derived compounds on May 31 from 8 a.m. to 6 p.m.
The FDA will have a hearing on scientific data and information about products containing cannabis or cannabis-derived compounds on May 31 from 8 a.m. to 6 p.m.
Provides Priority Regulatory Review of AI-Enabled Diagnostic for Fast-Progressing Kidney Disease
VivaQuant, a digital health company with powerful technology to accurately and efficiently identify and report cardiac arrhythmias, has received FDA clearance for its RX-1 wearable device.
Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market new visualization capabilities.
Opportunity to treat the underlying cause of CF earlier than ever before
Center for Tobacco Products incorporates machine learning platform to assist toxicology research
Company growth and customer adoption continues with hospitals and home healthcare agencies as the industry shifts to community-centric, value-based care
Phillips-Medisize, a Molex company, today announces the Little Rock, Arkansas facility is fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA. The facility is FDA 21 CFR part 820 compliant.
Committed to advancing solutions to the opioid addiction crisis, Purdue will not profit from nalmefene HCl
Belite Bio, a drug development company targeting currently untreatable conditions in ophthalmology and metabolic diseases, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for LBS-008 (BPN-14967), a first-in-class oral therapy for the treatment of atrophic Age-related Macular Degeneration (commonly known as dry AMD) and Stargardt disease, an inherited juvenile form of macular degeneration.
"The Optimal Solution" is a team of seasoned industry innovators cooperatively leveraging their expertise to demonstrate interoperability at scale in the pharma supply chain ecosystem. Team members include: RXTransparent, Systech, T-Systems, FarmaTrust, Cryptowerk and CalQLogic.
Food and Drug Administration Acting Commissioner Ned Sharpless announced a new FDA.org website to launch this week.
As part of a continuing effort to modernize and reform the oversight of dietary supplements, the Food and Drug Administration announced a public meeting on May 16 from 8:30 a.m. to 4 p.m. to canvass ideas on facilitating responsible innovation.
New Solution, Not Based on Acid Reduction, Found to Relieve Symptoms, Believed to Restore Localized Distal Esophageal Microbiome
As part of the U.S. Food and Drug Administration’s mission to protect the public health, outlined in our Medical Device Safety Action Plan, we are committed to continuing to strengthen and modernize how we take action to address device safety issues that emerge in the post-market in a more timely and effective way.
Voluntary recalls are one of the most important safety tools overseen by the U.S. Food and Drug Administration.
The FDA is a public health agency that always strives to use the best available scientific evidence to promote and protect the well being of individuals. I
Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), today announced that the US Food and Drug Administration has approved DUAKLIR® PRESSAIR® (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).