Tag: ClinicalTrials.gov

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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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REGISTRY SNAPSHOT: ClinicalTrials.gov

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This week in transparency news: January 19-25, 2019

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clinicaltrials.gov ct.gov fda clinical trial registry disclosure transparency services solutions trialassure technology clinical trials

This week in transparency news: January 12-18, 2019

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The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of previous noncompliance, and/or submitting misleading or false information to ClinicalTrials.gov. While the FDA has not previously begun issuing fines to pharmaceutical companies, this guidance brings that reality one step closer. Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking. Zach Weingarden, Product Solutions Manager, TrialAssure

Questions answered on FDA’s draft guidance on civil money penalties for ClinicalTrials.gov

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FDA issues draft guidance on civil monetary penalties for ClinicalTrials.gov clinical trial disclosure transparency trialassure company service solution technology software

This week in transparency news: September 15-28, 2018

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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

Inconsistent Clinical Trial Disclosure and Lack of Compliance Across Big Pharma

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