President Trump Issues Executive Orders for U.S. Manufacturing of Strategic Medical Supplies; Regulatory Relief

On May 14, President Trump signed an executive order to encourage the domestic production of  critical medical supplies. In the current pandemic, U.S. reliance on China for products such as personal protective equipment, ventilators, and antibiotics, has drawn increased interest in having critical drugs and medical devices manufactured in the homeland. The order would give […]

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Cambia Grove Impactful Innovation Exchange

How can we advance the utilization of innovations in healthcare? By lending them extra visibility to key stakeholders!   Impactful Innovation Exchange   Calling All Solutions!   Cambia Grove is launching the Impactful Innovation Exchange – a free comprehensive platform where health care stakeholders can search for emerging and/or proven innovations to solve their high […]

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Legal aspects of FDA regulatory Compliance: Preparing for an FDA Facility Inspection and Responding to a 483 Letter

Webinar In addition to evaluating data from adverse event reports, the bulk of FDA’s regulatory enforcement comes from its facility inspections and resulting 483 reports. This practical webinar will cover numerous aspects of preparing your drug or medical device establishment for a successful FDA facility inspection and responding to any post-inspection 483 letters. The key […]

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LabCorp Expands Access to At-Home COVID-19 Collection Test Kits; Lab Association Pushes for Federal Funding

On May 12, LabCorp announced that its COVID-19 at-home collection test kit is now available to individuals who have symptoms for COVID-19 as well as individuals without symptoms who may have been exposed to the virus. The diagnostic test, which uses a swab, is available through the company’s Pixel by LabCorp™ online platform.  Last month, […]

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House Democrats Move to Pass $3 Trillion COVID-19 Relief Package

House Democrats have proposed a new $3 trillion relief package, titled the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, which would increase funding for state and local governments, extend unemployment benefits, and designate special funding for frontline healthcare workers and first responders. Republicans have pushed back over the timing and priorities of the […]

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government & private funding resources for COVID-19 related products, medical technologies and drugs

Government to Growth Government to Growth (G2G) is led by Liz Powell, Esq., MPH, and includes a team of government affairs professionals who help startups, businesses and non-profits effectively navigate non-dilutive federal funding opportunities. With a specialty focus on life sciences, G2G tracks grants on a daily basis and produces a monthly GBG Report listing […]

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FDA Clears Park City-Based Transit Scientific’s XO Cross Microcatheter Platform

Park City, Utah USA, May 12, 2020 /PRNewswire/ — Transit Scientific announced the FDA cleared the XO Cross Microcatheter platform for guidewire support, exchange, and contrast media injection in the peripheral vasculature. Microcatheters are small 0.70-1.30mm outer diameter (OD) catheters used to provide guidewire support, facilitate guidewire exchanges, access distal anatomy, cross lesions, deliver therapeutic […]

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Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19

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For Immediate Release: May 11, 2020 Statement From: Commissioner of Food and Drugs – Food and Drug Administran Stephen M. Hahn M.D. During COVID-19, the U.S. Food and Drug Administration will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, […]

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