(Q36417844)

14 August 2017

Regulatory review of novel therapeutics--comparison of three regulatory agencies (English)

1 reference

14 August 2017

5

Harlan M Krumholz

1 reference

14 August 2017

Joseph S Ross

6

0 references

Nicholas L Downes

series ordinal

1

object named as

Nicholas S Downing

1 reference

14 August 2017

2

Jenerius A Aminawung

1 reference

14 August 2017

Nilay D Shah

3

1 reference

14 August 2017

Joel B Braunstein

series ordinal

4

1 reference

14 August 2017

language of work or name

English

0 references

publication date

16 May 2012

1 reference

The New England Journal of Medicine

14 August 2017

1 reference

14 August 2017

366

1 reference

14 August 2017

24

1 reference

14 August 2017

2284-2293

1 reference

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety

14 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3504361

Medical device innovation--is "better" good enough?

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3504361

Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3504361

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3504361

Drug-review deadlines and safety problems

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3504361

Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998.

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3504361

Interest groups jostle to influence PDUFA V

30 September 2017

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/22591257

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Medical devices and health--creating a new regulatory framework for moderate-risk devices

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/22591257

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1056/NEJMSA1200223

1 reference

14 August 2017

1 reference

14 August 2017

PubMed publication ID

22591257

1 reference