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A federal judge has ordered two individuals doing business as Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until they comply with federal law.
U.S. Food and Drug Administration publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI)
Leading Provider to National Pharmaceutical and Long-Term Care Industries Has 3-Ply Surgical and KN95 Masks In Stock, Ready to Ship Same Day.
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, located in Hyderabad India, recently received FDA approval for their generic versions of Oseltamivir Phosphate Capsules and Dofetilide Capsules.
New metal-alloy sheath converts angioplasty balloons into scoring and cutting systems
Marks 8th FDA clearance for BlueStar, the only reimbursable software as a medical device for diabetes that integrates with all of a patient's existing devices
The New 10 minute Antibody Test from Access Medical Labs sets a new standard after the CDC announced antibody testing may be wrong 50% of the time
CDC formally recommends daily health checks including temperature screening as U.S. businesses reopen
The Association of American Physicians & Surgeons (AAPS) filed a lawsuit, AAPS v. FDA, against the Food and Drug Administration to end its arbitrary interference with the use of hydroxychloroquine (HCQ), which President Trump and other world leaders have taken as a prophylaxis against COVID-19.
Compatibility plan includes testing representative samples of all commercially available CVCs and PIC
In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination.
The FDA has designated Laminate Medical's VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device.
The U.S. Food and Drug Administration and the National Telecommunications and Information Administration (NTIA) are launching a 120-day pilot to help reduce the availability of unapproved opioids illegally offered for sale online.
MNA nurses and healthcare professionals called for the halt of COVID-19 mask decontamination in April, finding lack of safety, efficacy evidence
New software can be used by pharma, biotech labs to comply with Title 21 CFR Part 11 data integrity regulations
Inspire Medical Systems CEO Tim Herbert has joined Nuvaira Board of Directors
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology.
High-Definition PCR SARS-CoV-2 assay increases test throughput and reduces complexity of interpretation; ChromaCode customers enjoy inventory guarantee
Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option
Virtual competition staged by National Capital Consortium for Pediatric Device Innovation (NCC-PDI) now accepting applications for devices addressing COVID-19 needs