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: Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

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.

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: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.

CEPHEID: Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test

Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

FDA: Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health

U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products.

BIOSTAGE: Announces IND Approval from FDA for its Lead Product Candidate Cellspan™ Esophageal Implant

Biostage, Inc. (OTCQB: BSTG) (Biostage or the Company), a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug application (IND) for the Cellspan Esophageal Implant (CEI) to treat patients with end-stage esophageal disease that require a segmental surgical resection to repair the diseased tissue.

FDA: Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.

FDA: Coronavirus (COVID-19) Update: Blood Donations

The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year.

FDA: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration.

ABBOTT: Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

The test will be used on the company's m2000 RealTime system that is currently available in hospitals and molecular laboratories in the U.S.

FDA: Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements

U.S. Food and Drug Administration took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.

FDA: Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics

As part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.

FDA: Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic

Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).

FDA Launches New Campaign to Help Consumers Use the New Nutrition Facts Label

The U.S. Food and Drug Administration today launched an initiative to help consumers use the new Nutrition Facts label that appears on packaged foods to maintain healthy dietary practices.

FDA Reporter