US food and drug administration efforts to facilitate the use of expanded access programs

Journal of Clinical Oncology

Volumn 33, Issue 33, 2015, Pages 3979-

  Kim, Tamy ^a   Lurie, Peter ^a   Pazdur, Richard ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

BLINATUMOMAB; NIVOLUMAB; PALBOCICLIB; PEMBROLIZUMAB; NEW DRUG;

COMPASSIONATE USE; DRUG APPROVAL; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PLANNING; LETTER; MEDICAL SOCIETY; PRIORITY JOURNAL; DRUG CONTROL; EXPERIMENTAL THERAPY; HEALTH CARE DELIVERY; HUMAN; LEGISLATION AND JURISPRUDENCE; PATIENT RIGHT; TERMINAL CARE;

DRUG AND NARCOTIC CONTROL; DRUGS, INVESTIGATIONAL; HEALTH SERVICES ACCESSIBILITY; HUMANS; PATIENT RIGHTS; TERMINAL CARE; THERAPIES, INVESTIGATIONAL;

EID: 84948421710     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.63.4139     Document Type: Letter

References (6)

1. Lieu CH, Sorkin A, Messersmith WA: Right to try? J Clin Oncol 33:1518, 2015
2. Darrow JJ, Sarpatwari A, Avorn J, et al: Practical, legal, and ethical issues in expanded access to investigational drugs. N Engl J Med 372:279-286, 2015
3. Lurie P, Chan-Tack K, Woodcock J: Expanded access to investigational drugs. N Engl J Med 372:1473, 2015
4. Draft Guidance for Industry: Individual Patient Expanded Access Applications: Form FDA 3926. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM432717.pdf
5. US Food and Drug Administration: Expanded access (compassionate use). http://www.fda.gov/expandedaccess
6. US Food and Drug Administration: Manual of Policy and Procedures (MAPP 6025.6): Office of New Drugs, Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM407009.pdf