Searching Content indexed under Healthcare by Mark Barnes ordered by Published Date Descending.
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What OIG Self-Disclosure Guidance Means For HHS Grantees
This article by counsel Valerie Bonham and partners Kirsten Mayer and Mark Barnes was published by Law360 on August 8, 2019.
United States
14 Aug 2019
HHS OIG Issues Self-Disclosure Program Guidance For Research Grants And Contracts
Universities, academic medical centers, companies and other recipients and sub-recipients of federal biomedical and basic research funds are under increased scrutiny and facing stiffer
United States
30 Jul 2019
NIH Issues New Guidance On "Other Support" And "Foreign Components" In Funded Research
In the wake of ongoing concerns expressed about "foreign influence" in U.S.-funded research activities, the National Institutes of Health (NIH) last week released
United States
24 Jul 2019
India Finalizes Rules Regarding Compensation For Subjects Injured In Clinical Trials And Post-Trial Access To Study Drugs
Since 2013, India's clinical trials regulatory framework has undergone continuous, significant changes to bolster protections for clinical trial participants.
United States
7 May 2019
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
A Modern Approach To Digital Health Product Regulation
As part of an overarching initiative to update its regulatory oversight of digital health technologies, the U.S. Food and Drug Administration has announced new plans to streamline the development...
United States
9 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18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs).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
China Announces Revised Good Clinical Practices For Public Comments
The China Food and Drug Administration recently released its proposed revisions to Good Clinical Practices ("GCP") for pharmaceutical clinical studies for public comments.
United States
16 Feb 2015
European Union Negotiations Reach Agreement On New Clinical Trials Regulation
The European Union ("EU") has cleared the way for adoption of a new clinical trials regulation within the EU.
European Union
23 Jan 2014
OMB Publishes Final Uniform Guidance On Administrative Requirements, Cost Principles, And Audit Requirements For Federal Awards
On December 26, 2013, the Office of Management and Budget ("OMB") published final guidance in the Federal Register entitled "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards" ("Final Guidance"), to be located at Title 2 of the Code of Federal Regulations ("C.F.R.").
United States
6 Jan 2014
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