GBC Blog

The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance

QUALITY & COMPLIANCE03.5.2019 Robert Fenton In 2017, the FDA issued 218 more warning letters for 21 CFR 820 than they did the previous year. The 21 CFR 820 regulation, which the FDA uses to monitor the design, manufacturing, packaging, labeling, storage, installation, and servicing for products, ensures that companies create high-quality materials. For a medical device, drug, bioresearch,…

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Help Protect the Breakthroughs of Tomorrow (www.innovation.com)

In recent years, rapid advances in scientific discovery have ushered in a new era of medicine. But despite progress, Washington is considering policies that threaten the ability of America’s biopharmaceutical researchers to continue researching and developing new treatments and cures. We’re advocating for the latest innovations so we can continue to go boldly, together. www.innovation.org http://innovation.org/about-us/campaigns/breakthrough

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Geisinger to Offer DNA Sequencing to All Its Patients

Philadelphia Business Journal, May 7, 2018, 11:34am EDTPennsylvania-based Geisinger Health System is taking routine health screenings for patients beyond the typical mammograms, colonoscopies and cholesterol tests. It will soon be adding DNA sequencing to its list of recommended preventative care measures for patients. “Understanding the genome warning signals of every patient will be an essential…

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Discovery Life Sciences Launches Major European Expansion

HUNTSVILLE, Ala., Feb. 13, 2019 /PRNewswire/ — Discovery Life Sciences™ (Discovery) announced a major expansion into Europe today, acquiring Sofia Bio and its extensive network of human biospecimen collection sites in Bulgaria, Romania, Poland, and the Czech Republic. Discovery also has entered into an agreement to become the exclusive industry distributor of East West Biopharma, which maintains the largest biocollection network in Ukraine. These initiatives cement…

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Four Life Science Companies Merge into Discovery Life Sciences

Published: Oct 16, 2018 By Mark Terry Discovery Life Sciences, a leading research biobank located in Los Osos, California, recently got much, much bigger via a four-company merger. Ann Dover, Discovery’s founder, president and chief executive officer, took time to speak with BioSpace about the merger and the new identity of the company. The four companies involved in the…

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Only a Tenth of the Human Genome is Studied

The Economist / Science and Technology, Sep 20th 2018 ONE tale of Nasreddin, a self-satirising 13th-century philosopher, tells of the time he lost a precious ring. When his wife asks why he is searching in the yard rather than inside, where the ring was lost, Nasreddin explains that the light is better outside. Looking for…

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Discovering the Ancient Origin of Cystic Fibrosis, The Most Common Genetic Disease in Caucasians

https://theconversation.com/discovering-the-ancient-origin-of-cystic-fibrosis-the-most-common-genetic-disease-in-caucasians-100499 Imagine the thrill of discovery when more than 10 years of research on the origin of a common genetic disease, cystic fibrosis (CF), results in tracing it to a group of distinct but mysterious Europeans who lived about 5,000 years ago. CF is the most common, potentially lethal, inherited disease among Caucasians – about…

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The New Era of Medicine (www.innovation.org)

WELCOME TO THE NEW ERA OF MEDICINE Finding lifesaving treatments is our life’s work—the work of the 140,000 biopharmaceutical researchers who boldly leap into the unknown to pioneer tomorrow’s breakthrough cures. It’s also the work of millions of patients who fight against whatever obstacles they face. http://innovation.org/ http://innovation.org/latest-articles

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Seattle’s INDI Acquired by Lung Cancer Tech Company Biodesix

Seattle’s Integrated Diagnostics Acquired by Lung Cancer Technology Company Biodesix Colorado-based Biodesix, a company that creates technology around lung cancer, announced that it has acquired Seattle’s Integrated Diagnostics for an undisclosed sum. Integrated Diagnostics, also known as Indi, develops a test that can rule out patients who do not have lung cancer using a simple…

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