Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by David Peloquin ordered by Published Date Descending.
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INSIGHT: Will Consent Be Disfavored As Basis For Processing Personal Data In Clinical Research Under EU Data Protection Law?
The European General Data Protection Regulation, which took effect on May 25, 2018, requires that all processing of personal data subject to the GDPR must have a legal basis under the GDPR's Article 6.
European Union
19 Jun 2018
Proposed Rule Would Delay Common Rule General Compliance Date Until January 21, 2019 While Permitting Earlier Implementation Of Three "Burden-Reducing" Provisions
The January 2018 Interim Final Rule stated that the general compliance date may be subject to additional delay through further rulemaking.
United States
24 Apr 2018
Video: Life Sciences Quarterly: The Use Of Social Media And Mobile Applications In Clinical Trials & Recent Developments In Research Fraud
What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations?
United States
14 Dec 2017
OIG's Warranty Safe Harbor Opinion And Value-Based Care
In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General clarified the scope of the Anti-Kickback Statute warranty safe harbor.
United States
20 Sep 2017
What To Know About New FDA Informed Consent Guidance
On July 25, 2017, the U.S. Food and Drug Administration issued a guidance document1 announcing its intention not to object to an institutional review board's (IRB) waiving or altering of the informed consent requirements for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections.
United States
15 Aug 2017
FDA Indefinitely Delays Action On Regulating Laboratory Developed Tests
On November 18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs).
United States
24 Nov 2016
One Step Away: European Parliament Approves New Clinical Trials Regulation
The European Parliament approved the new clinical trials regulation for the European Union, with 594 votes in favor, 17 opposed and 13 abstentions.
European Union
14 Apr 2014
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