Monday, March 30, 2020

Monday, March 30, 2020

Latest News

MCRA: Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

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.

MESA BIOTECH: Receives Emergency Use Authorization from FDA for a 30 Minute Point of Care Molecular COVID-19 Test

Easy to use, palm-sized system will enable broader use across healthcare facilities closer to the patients and will begin shipping immediately

NEXVOO: The NEXVOO® factory operates as a Healthcare Certified Factory in Xiamen, China with a direct sourcing partnership to ship FDA Certified N95 Masks

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.

ALIVECOR: New FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients

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.

BIOHAVEN: To Advance Vazegepant into Phase 3 for the Acute Treatment of Migraine Following Successful End of Phase 2 Meeting with FDA

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

FDA: Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic

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.

FDA Reporter