(Q36087521)

12 August 2017

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study (English)

1 reference

12 August 2017

0 references

Bo Wang

2

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:26400751%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

Jessica M Franklin

series ordinal

3

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:26400751%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

language of work or name

English

0 references

publication date

23 September 2015

1 reference

12 August 2017

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:26400751%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

volume

351

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:26400751%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

page(s)

h4633

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:26400751%20AND%20SRC:MED&resulttype=core&format=json

The 21st Century Cures Act--Will It Take Us Back in Time?

3 June 2020

cites work

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Health Canada's use of its priority review process for new drugs: a cohort study

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs.

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

New FDA breakthrough-drug category--implications for patients.

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Accelerated approval of oncology products: the food and drug administration experience

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Drug-review deadlines and safety problems

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

The risk we bear: the effects of review speed and industry user fees on new drug safety

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Biological products; bacterial vaccines and toxoids; implementation of efficacy review. Final rule and final order.

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Changes in FDA drug classification and priority review policy

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Drug development and FDA approval, 1938-2013.

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

The Food and Drug Administration Amendments Act and postmarketing commitments.

23 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Surrogate outcomes in clinical trials: a cautionary tale

23 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked?

23 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

The Accelerated Approval of Oncologic Drugs

23 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4580726

Why do cancer drugs get such an easy ride?

21 October 2018

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/26400751

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010?

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/26400751

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/26400751

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1136/BMJ.H4633

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:26400751%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:26400751%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

PubMed publication ID

26400751

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:26400751%20AND%20SRC:MED&resulttype=core&format=json