Advanced search
Publication Cover
Expert Opinion on Orphan Drugs Volume 1, 2013 - Issue 7
Submit an article Journal homepage
1,147
Views
6
CrossRef citations to date
0
Altmetric
Editorials

Expedited programs for drug development and approval

Anne R PariserOffice of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20993, [email protected]
, MD (Associate Director for Rare Diseases) ,
Melissa RobbAssociate Director for Regulatory Affairs, Office of Medical Policy Initiatives, Office of Medical Policy (OMP), CDER, FDA, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA
&
Rachel E Sherman OMP, CDER, FDA, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA
, MD MPH (Associate Director for Medical Policy)
Pages 507-510 | Published online: 31 May 2013

Citations (6)

Keep up to date with the latest research on this topic with citation updates for this article.

Subscribe to citation updates

Read on this site (2)

Nikolaos Giagkou & Maria Stamelou. (2019) Emerging drugs for progressive supranuclear palsy. Expert Opinion on Emerging Drugs 24:2, pages 83-92.
Read now
Dale E Johnson. (2014) Fast-tracking an orphan drug indication within a broader development project. Expert Opinion on Orphan Drugs 2:2, pages 107-111.
Read now

Articles from other publishers (4)

Vikram M. Narayan & Philipp Dahm. (2019) The future of clinical trials in urological oncology. Nature Reviews Urology 16:12, pages 722-733.
Crossref
Makoto Tanaka, Naoki Matsumaru & Katsura Tsukamoto. (2019) Influence of Expedited Programs in the United States on Oncology Drug Development in Japan. Therapeutic Innovation & Regulatory Science 53:2, pages 199-206.
Crossref
Makoto Tanaka, Naoki Matsumaru & Katsura Tsukamoto. (2018) Influence of Breakthrough Therapy Designation in the United States on Oncology Drug Development Timelines in Japan. Pharmaceutical Medicine 32:3, pages 201-207.
Crossref
Emil D Kakkis, Mary O’Donovan, Gerald Cox, Mark Hayes, Federico Goodsaid, PK Tandon, Pat Furlong, Susan Boynton, Mladen Bozic, May Orfali & Mark Thornton. (2015) Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints. Orphanet Journal of Rare Diseases 10:1, pages 16.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.