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1
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
2
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
3
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
4
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
5
New GDPR Guidance From European Commission On Interaction Between EU Clinical Trials Regulation And GDPR
On April 10, 2019, the European Commission Directorate-General for Health and Food Safety (the "EU Commission") issued new guidance (the "Q&A")
European Union
6 May 2019
6
GDPR Complicates Admissions Applications For U.S. Universities
The European Union General Data Protection Regulation, Regulation (EU) 2016/679, which became effective May 25, 2018, poses compliance challenges for some longstanding admissions practices of U.S. universities ...
United States
2 Jul 2018
7
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
8
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
9
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
10
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
11
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
12
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
13
China FDA Clarifies Legal Consequences Of Clinical Trial Data Inspections
China's recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable.
China
31 Aug 2016
14
European Commission Releases Text Of Proposed Privacy Shield Agreement For Transfer Of European Union Citizen Data To The United States
On February 29, 2016, the European Commission released the full text of the proposed EU-U.S. Privacy Shield agreement, a data protection self-certification framework for companies transferring EU citizen data to the United States.
European Union
8 Mar 2016
15
The U.S.-EU Safe Harbor Framework Is Invalid: Now What?
A confluence of events has tested the strength of the Safe Harbor Framework and for now, it is no longer a port in the storm.
Worldwide
12 Oct 2015
16
EU - US Personal Data Transfers - Safe Harbor Under Threat
Following a private challenge by an Austrian law student to the storage by Facebook of his personal data on servers located in the United States, the EU Advocate General has filed an advisory opinion with the European Court of Justice recommending that the EU-U.S. safe harbor of privacy principles be invalidated.
Worldwide
28 Sep 2015
17
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
18
China Issues Draft Guidance On Multi-Regional Clinical Trials
On November 21, 2014, China Food and Drug Administration ("CFDA") released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) ("Guidance") for public comments through December 21.
China
26 Nov 2014
19
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
20
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
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