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Tag: FDAAA

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The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of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 Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking.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

Common clinical trial transparency questions, answered!

by Staff Writer | November 2018

Posted in Blog
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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

by Staff Writer | December 2015

Posted in Blog
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National Institute of Mental Health (NIMH) trialassure

Clinical Trial Disclosure: More “FDA” Needed in Past and Present Acts

by Staff Writer | November 2012

Posted in Blog
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