(Q36252596)

13 August 2017

Understanding Food and Drug Administration regulatory requirements for an investigational device exemption for sponsor-investigators (English)

1 reference

13 August 2017

M E Blair Holbein

1

1 reference

PMCID

3448842

13 August 2017

Jelena Petrovic Berglund

series ordinal

2

1 reference

13 August 2017

1 October 2012

1 reference

Journal of Investigative Medicine

13 August 2017

1 reference

13 August 2017

60

1 reference

13 August 2017

7

1 reference

13 August 2017

987-994

1 reference

Planning for effective interaction with FDA.

13 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3448842

PubMed Central

reference URL

Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3448842

PubMed Central

reference URL

Clinical trial registration: a statement from the International Committee of Medical Journal Editors.

22 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3448842

PubMed Central

reference URL

10.2310/JIM.0B013E318262DF40

22 September 2018

Identifiers

DOI

1 reference

13 August 2017

1 reference

13 August 2017

1 reference

PMCID

3448842