Category: Blog

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CSR pilot FDA releases first clinical study report in data transparency pilot program trialassure fdaaa section 801 requirements fdaaa trials tracker

This week in transparency news: April 6 – April 12, 2019

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TrialAssure In support of an ongoing effort to increase transparency, Health Canada intends to implement five proposals related to prescription drugs and biologics by October 1, 2018. The proposals come from a division within Health Canada—the Health Products and Food Branch (HPFB)—as part of two 2015 transparency initiatives for drugs, biologics and medical devices.

This week in transparency news: March 30 – April 5, 2019

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Should people share their DNA for drug development purposes? – USA Today Many people don’t realize that sharing a DNA sample with Ancestry.com, 23andMe and others can result in their data being shared. However, this week, the companies pledged that they would disclose when data is shared with corporations or the government. With a $300 million investment by GSK in 23andMe, they state that approximately 80 percent of customers have agreed to share their DNA data. This data is being de-identified before it is shared.

This week in transparency news: March 23 – March 29, 2019

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This week in transparency news: March 16 – March 22, 2019

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This week in transparency news: March 2 – March 15, 2019

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This week in transparency news: February 23 – March 1, 2019

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This week in transparency news: February 16 – February 22, 2019

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Should people share their DNA for drug development purposes? – USA Today Many people don’t realize that sharing a DNA sample with Ancestry.com, 23andMe and others can result in their data being shared. However, this week, the companies pledged that they would disclose when data is shared with corporations or the government. With a $300 million investment by GSK in 23andMe, they state that approximately 80 percent of customers have agreed to share their DNA data. This data is being de-identified before it is shared.

This week in transparency news: February 9 – February 15, 2019

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The U.S. Senate had voted in favor of an opioid bill that expands Open Payments to include payments made to Nurse Practitioners, Physician Assistants, Nurse Midwifes, Nurse Anesthetists, and Clinical Nurse Specialists, in addition to current physician reporting requirements. This will go into effect beginning January 1, 2022. Inconsistent Clinical Trial Disclosure and Lack of Compliance Across Big Pharma

This week in transparency news: February 2 – February 8, 2019

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This week in transparency news: January 26 – February 1, 2019

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