Navigation Links
NDA Partners Supports Successful EUA by FDA for Expedited Approval of COVID-19 At-home Diagnostic Test Kit
Date:6/4/2020

NDA Partners Chief Executive Officer Earle Martin announced today that its client, PrivaPath Diagnostics, Inc. (also known as LetsGetChecked), successfully received an Emergency Use Authorization (EUA) from the FDA for LetsGetChecked Coronavirus (COVID-19) Test, a convenient, at-home diagnostic test kit for detection of the COVID-19 coronavirus (SARS-CoV-2). NDA Partners Expert Consultants provided regulatory advisory services to support the preparation and submission of the EUA. PrivaPath received notification of approval from the FDA in May.

Dr. David Feigal, Manager of NDA Partners’ medical device practice, praised PrivaPath’s accomplishment: “PrivaPath’s new diagnostic for home use will play an important role in addressing the public health challenges of COVID-19 and controlling its spread. We were pleased to support PrivaPath’s efforts and congratulate them on this significant contribution to personal and public safety. We look forward to supporting other companies developing critical medical products, diagnostic tests, and therapies to combat the COVID-19 pandemic.”

About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

About PrivaPath Diagnostics, Inc.
PrivaPath Diagnostics (“PrivaPath”) is the holding company for LetsGetChecked, a consumer-based diagnostics company developing an at-home health testing platform that connects customers to regulated laboratory testing to better manage and control one’s individual health. LetsGetChecked is making healthcare and diagnostics open and patient-led, empowering people to use technology in a simple but powerful way and giving consumers greater control over their personal health. The Company is headquartered in New York, New York, with tests covering general wellness, sexual health, women’s health and men’s health, and is available nationwide, as well as in Canada and Europe.

Contact
Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle@ndapartners.com

Read the full story at https://www.prweb.com/releases/nda_partners_supports_successful_eua_by_fda_for_expedited_approval_of_covid_19_at_home_diagnostic_test_kit/prweb17167342.htm.


'/>"/>
Source: PRWeb
Copyright©2020 Vocus, Inc.
All rights reserved


Related medicine news :

1. Allegheny Health Network Partners with Region’s EMS Providers to Advance Treatment of Heart Attack Patients
2. Yogafit Partners With Wholebeing Institute, Bringing Positive Psychology Into Yoga Therapy Training
3. BeachLifestyle and The Total Education Network Announce Their Partnership as the Simply G Media Network
4. Maine Biotechnology Services-USDA-ARS Partnership Provides Monoclonal Antibodies to Aid in the Containment of Rift Valley Fever Virus
5. Tunstall Americas Partners with Faith Tele-health dba Concierge Care Transition to Pilot New Transitional Care Service
6. Zamzee® Partners with Safe Routes to School™ Initiative in West Coast Communities
7. Humility of Mary Health Partners Names Kathy Cook New President of St. Joseph Health Center
8. PolyU Gears Up for Aviation Services Research in Partnership with Boeing
9. U.S.-based Children’s Medical Charity Mobilizes Global Partners Aiding Operation Smile’s Philippine Foundation Post-Typhoon
10. National MS Society partners with Accelerated Cure Project Online Forum to drive progress
11. Zing Partners LLC Announces US Patent and Trademark Office Approval of Zippy Soother Design Patent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/2/2020)... , ... July 02, 2020 , ... ... annual Outstanding Safety Professional of the Year Award to Eric Simmons of Temecula, ... more than 250 nominations. Simmons, who holds a master’s degree in occupational safety ...
(Date:7/2/2020)... ... July 02, 2020 , ... ... including dental offices for non-emergency work. In conjunction with the American Dental Association ... Connecticut dental practices in mid-May. , Due to safety concerns, the announcement ...
(Date:7/1/2020)... Calif. (PRWEB) , ... July 01, 2020 , ... ... of cannabis and botanically-derived terpenes, has officially released its new terpene infused ... brands a way for consumers to enjoy cannabis terpene profiles and flavors worldwide. ...
(Date:7/1/2020)... ... July 01, 2020 , ... ... Salvador, MD, Associate Professor of Medicine at the University of Massachusetts Medical School- ... Strategies, LLC have joined the SIDM Board of Directors. Dr. Salvador and Ms. ...
(Date:6/28/2020)... , ... June 26, 2020 , ... ... for participation in the revision and redesignation of the ANSI/APSP/ICC-7 2013 American National ... and Catch Basins. PHTA is seeking member participation on the PHTA-7 Standard Writing ...
Breaking Medicine News(10 mins):
(Date:6/25/2020)... LEXINGTON, Mass. (PRWEB) , ... June 25, 2020 ... ... its 27th annual International Research Congress (IRC) , which is being conducted ... widely seen as the premier global platform for the discussion and dissemination of ...
(Date:6/24/2020)... , ... June 24, 2020 , ... The Safe Boating ... Fourth of July. Boating under the influence, or BUI, is the leading contributing factor ... holiday is around the corner, and unfortunately has become known for drinking and boating, ...
(Date:6/23/2020)... ... 2020 , ... Draper today announced the release of a ... test an in vitro human lung model to investigate responses following infection with ... and the University of Massachusetts Medical School . The manuscript, titled ...
Breaking Medicine Technology: