Breakthrough Therapy Designation: Bringing Innovation Swiftly to Patients

Therapeutic Innovation and Regulatory Science

Volumn 49, Issue 2, 2015, Pages 256-261

  Shah, Arpita ^a  

^a CELGENE CORPORATION   (United States)

Author keywords

breakthrough therapies; expedited programs for serious conditions; FDA

Indexed keywords

PRESCRIPTION DRUG;

ARTICLE; BREAKTHROUGH THERAPY; CLINICAL DEVELOPMENT PLAN; COMPARATIVE STUDY; DISEASE COURSE; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG THERAPY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL;

EID: 84924766393     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479014558272     Document Type: Article

References (14)

1. Pub L No. 112-144, § 902. http://www.gpo.gov/fdsys/pkg/PLAW-122publ144/pdf/PLAW-122publ144.pdf. Accessed May 2, 2013.
2. Food and Drug Administration. Guidance for industry: expedited programs for serious conditions—drugs and biologics. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf. Accessed June 30, 2014.
3. Friends of Cancer Research. Inside health policy—FDA official: breakthrough designation brings high bar, costly investment. http://www.focr.org/breakthrough-therapies. Accessed July 10, 2013.
4. The Pink Sheet. A regulator’s perspective for 2013: FDA’s temple discusses FDASIA, Caronia, and breakthrough development. http://www.pharmamedtechbi.com/publications/rpm-report/9/2/a-regulators-perspective-for-2013-fdas-temple-discusses-fdasia-emcaroniaem-and-breakthroug. Accessed June 22, 2013.
5. US Food and Drug Administration. Frequently asked questions: breakthrough therapies. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm341027.htm. Accessed July 29, 2013.
6. US Food and Drug Administration. Fact sheet: breakthrough therapies. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm329491.htm. Accessed August 6, 2013.
7. Federal Register. Center for Drug Evaluation and Research medical policy council; request for comments. https://www.federalregister.gov/articles/2013/03/18/2013-06142/center-for-drug-evaluation-and-research-medical-policy-council-request-for-comments. Accessed June 30, 2014.
8. Pharma & MedTech Business Intelligence. What makes a “breakthrough” therapy? Woodcock says more details are coming. http://www.pharmamedtechbi.com/publications/rpm-report/first-take/2013/5/woodcock-on-breakthrough. Accessed September 18, 2013.
9. Fierce Biotech. Industry voices: breakthrough designation Q&A. http://www.fiercebiotech.com/story/industry-voices-breakthrough-designation-qa/2013-09-11. Accessed October 21, 2013.
10. FDA. Genentech approval letter: Gazyva. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125486Orig1s000ltr.pdf. Accessed December 2, 2013.
11. FDA. Novartis approval letter: Zykadia. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205755Orig1s000ltr.pdf. Accessed May 30, 2014.
12. FDA. Pharmacyclics approval letter: Imbruvica. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205552Orig1s000ltr.pdf. Accessed January 14, 2014.
13. OBR Daily. Will the breakthrough designation shorten development times for oncology agents currently in the pipeline?http://www.obroncology.com/blog/2013/12/will-the-breakthrough-designation-shorten-development-times-for-oncology-agents-currently-in-the-pipeline/. Accessed January 20, 2014.
14. Fierce Biotech. Ariad Pharma denied FDA’s coveted “breakthrough” stamp for lung cancer drug. http://www.fiercebiotech.com/story/ariad-pharma-denied-fdas-coveted-breakthrough-stamp-lung-cancer-drug/2013-08-09. Accessed October 15, 2013.