Pearlpathways.com

FDA announces CDRH reorganization – How will medical device

WebOn March 13, 2019 the U.S. Food and Drug Administration (FDA) announced The Center for Devices and Radiological Health (CDRH) is beginning implementation of a …

Actived: 4 days ago

URL: https://www.pearlpathways.com/fda-announces-cdrh-reorganization-how-will-medical-device-manufacturers-be-impacted/

FDA expands guidance on pediatric drug development with new …

WebThe new guidance, ICH E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population, does not alter the scope of the original …

Category: Health Go Health

Medical technologies are advancing quickly. How is FDA keeping …

WebDigital health, targeted medicines, and regenerative medicine are just a few relatively new technologies pushing the life science industry forward at an accelerated pace.

Category: Medicine Go Health

Current clinical research model is at risk due to the slow …

WebPearl Pathways is a comprehensive life science product development services company. Every day we strive to provide our customers top quality service, …

Category: Health Go Health

Versiti Acquires Indianapolis-based Pearl Pathways

WebVersiti, a national leader in blood health innovation, today announced the acquisition of Pearl Pathways, a recognized, trusted advisor and preferred partner for …

Category: Health Go Health

What is an FDA guidance document

WebFDA guidance document: A brief history. FDA’s authority to regulate stems from the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the Public Health …

Category: Food Go Health

Breakthrough devices receive new FDA draft guidance, program …

WebThe 21 st Century Cures Act paved the way for a new program for breakthrough medical devices. On Tuesday, October 24 th, the US Food and Drug …

Category: Food, Medical Go Health

Fighting the Life Science Talent Shortage – Diana Caldwell, Pearl

WebDiana Caldwell, President and CEO of Pearl Pathways, is featured in two articles in the 2018 issue of BioFutures.BioFutures is an annual publication of the Indiana …

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Pre-Clinical Pathways: Start Off On the Right Foot

WebRobert Seevers, Senior Advisor at Pearl Pathways, will share insights during an Indiana Health Industry Forum (IHIF) webinar on Tuesday, March 16, 2021. The …

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Cara Frosch, MBA, PA

WebCara Frosch serves as the Chief Business Officer for Pearl Pathways and has over 25 years of diversified biopharmaceutical and medical device development experience in human …

Category: Medical Go Health

Industry Links & Resources

WebPearl Pathways is a comprehensive life science product development services company. Every day we strive to provide our customers top quality service, unyielding ethics, and …

Category: Health Go Health

Digital Therapeutics and FDA Regulations

WebThe use of digital therapeutics (DTx) is on the rise. Fueled by shifting models of care as a result of the coronavirus pandemic, the DTx market is expected to reach …

Category: Coronavirus Go Health

Regulatory Strategy and Global Filings

WebOur team also has the expertise to format, compile, publish, and submit your bio-pharmaceutical regulatory submission electronically through FDA’s Electronic …

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Get Up to Speed on the ABCs of Global Regulatory Filings

WebGet Up to Speed on the ABCs of Global Regulatory Filings. by Waylon Wright | Nov 22, 2021. One challenge to getting acclimated with the drug approval …

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FDA announces they will not regulate “low risk” general wellness

WebWhile mobile health apps and wearable devices have become exponentially more popular, FDA has explained they will not be regulating “low risk” general wellness …

Category: Health Go Health