As part of the U.S. Food and Drug Administration’s ongoing commitment to combatting the coronavirus (COVID-19) pandemic and providing flexibility across FDA-regulated industries, the agency announced that it intends to temporarily not enforce certain requirements in order to allow veterinarians to better utilize telemedicine to address animal health needs during the pandemic.
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process.
In previously reported positive topline results from pivotal Phase 2/3 clinical trial in December 2019, vazegepant achieved statistical superiority to placebo on the co-primary regulatory endpoints of pain freedom and freedom from most bothersome symptom at 2 hours
World's only FDA-cleared six-lead personal ECG will be used by healthcare professionals to monitor QT duration in patients receiving medications that can cause potentially life threatening QT prolongation.
NEXVOO®, a global innovation leader in unified communications products, announces that it is assisting with the US and global pandemic by shifting resources to help with shipping FDA Certified N95 mask supplies into the US.
Easy to use, palm-sized system will enable broader use across healthcare facilities closer to the patients and will begin shipping immediately
MCRA, LLC, a leading medical device advisory firm and CRO with specialization in regulatory affairs, clinical research, reimbursement, compliance, and quality assurance, has implemented a call center to keep medical device manufacturers informed of government and site decisions that impact regulatory submissions, clinical study operations, or quality systems as a result of the COVID-19 pandemic.
The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19, as part of our commitment to ease burdens on the health care system during this pandemic.
During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products.
Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.
EIDD-2801, an oral broad-spectrum antiviral proceeding into Clinical Trials
Halo Labs, a life science instrumentation company developing tools for biologics researchers, announced it has closed a $12M Series B1 financing round led by Research Corporation Technologies (RCT).
Future Use in Outbreak Management Expected, via DARPA Partnership
Amid COVID-19 pandemic, remote healthcare solutions are a priority now more than ever
Hand Sanitizer Utilizing FDA/CDC Approved Formula Begins Shipping this Week
FDA has declared the COVID-19 outbreak a public health emergency and implemented an expedited pathway to market authorization for products crucial in addressing this crisis, the Emergency Use Authorization (EUA).
Agency Continues Effort to Protect Public Health from Fraudulent and Harmful Products
Registration as an over-the-counter drug manufacturer to prepare alcohol-based hand sanitizers accelerates anticipated timeline to initial production
The Boston-based green chemistry company's trial will study the industry's first all-natural, silk-based dermal filler
The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings.