Drug development in serious diseases: The new "breakthrough therapy" designation

Clinical Pharmacology and Therapeutics

Volumn 95, Issue 5, 2014, Pages 483-485

  Woodcock, J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CHILDHOOD DISEASE; CYSTIC FIBROSIS; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEALTH PROGRAM; HUMAN; LAW; PRIORITY JOURNAL; REIMBURSEMENT; REVIEW; RISK ASSESSMENT; STANDARD; STEADY STATE;

DRUG APPROVAL; DRUG DESIGN; DRUGS, INVESTIGATIONAL; ENDPOINT DETERMINATION; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84898927952     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2014.23     Document Type: Review

References (2)

1. US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Draft guidance 〈http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/UCM358301.pdf〉 (June 2013).
2. US Food and Drug Administration. Code of Federal Regulations, Title 21, Vol. 5 (rev. 1 April 2013). Accelerated approval of new drugs for serious or life-threatening illnesses. 21 CFR 314.500, Subpart H.