(Q35588414)

9 August 2017

0 references

Registries, research, and regrets: is the FDA's post-marketing REMS process not adequately protecting patients? (English)

1 reference

9 August 2017

Norman J Kachuck

1

1 reference

9 August 2017

publication date

1 November 2011

1 reference

Therapeutic advances in neurological disorders

9 August 2017

published in

1 reference

9 August 2017

volume

4

1 reference

9 August 2017

issue

6

1 reference

9 August 2017

page(s)

339-347

1 reference

Asymptomatic reactivation of JC virus in patients treated with natalizumab

9 August 2017

cites work

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3229256

The REMS publication paradox

27 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3229256

Shattuck lecture. Innovation, regulation, and the FDA.

27 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3229256

Risk evaluation and mitigation strategies: impact on patients, health care providers, and health systems

26 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3229256

Progressive multifocal leukoencephalopathy after natalizumab monotherapy

26 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3229256

Reemergence of PML in natalizumab-treated patients--new cases, same concerns

26 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3229256

A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

26 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3229256

New FDA regulation to improve safety reporting in clinical trials

26 September 2018

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/22164188

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/22164188

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Effect of internal reporting criteria on suspected adverse drug reactions submitted to MedWatch

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/22164188

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1177/1756285611424461

1 reference

9 August 2017

1 reference

9 August 2017

1 reference