Engaging patients across the spectrum ofmedical product development view from the us food and drug administration

JAMA - Journal of the American Medical Association

Volumn 314, Issue 23, 2015, Pages 2499-2500

  Hunter, Nina L ^a   O'Callaghan, Kathryn M ^a   Califf, Robert M ^b  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER; DEVICE APPROVAL; DRUG APPROVAL; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PLANNING; HEALTH CARE SYSTEM; HEALTH PROGRAM; HUMAN; MEDICAL DECISION MAKING; MEDICAL DEVICE REGULATION; MEDICAL SOCIETY; OUTCOME ASSESSMENT; PATIENT CARE; PATIENT PARTICIPATION; PATIENT PREFERENCE; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; RISK BENEFIT ANALYSIS; SHORT SURVEY; ADVISORY COMMITTEE; DEVICES; NEEDS ASSESSMENT; ORGANIZATION AND MANAGEMENT; PROCEDURES; UNITED STATES;

BIOLOGICAL PRODUCT; DRUG;

ADVISORY COMMITTEES; BIOLOGICAL PRODUCTS; EQUIPMENT AND SUPPLIES; HUMANS; NEEDS ASSESSMENT; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT PARTICIPATION; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84950138272     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2015.15818     Document Type: Short Survey

References (7)

1. Hunter NL, Califf RM. FDAs patient preference initiative: The need for evolving tools and policies. http://blogs.fda.gov/fdavoice/index.php/2015/09/fdas-patient-preference-initiative-The-need-for-evolving-Tools-And-policies/. Accessed September 28, 2015.
2. Gallin EK, Bond E, Califf RM, et al. Forging stronger partnerships between academic health centers and patient-driven organizations. Acad Med. 2013;88(9):1220-1224.
3. US Food and Drug Administration. How to study and market your device. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. Accessed October 23, 2015.
4. Medical Device Innovation Consortium (MDIC). MDIC website. http://mdic.org/. Accessed October 23, 2015.
5. US Food and Drug Administration. Draft guidance on patient preference information. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446680.pdf. Accessed November 17, 2015.
6. US Food and Drug Administration. Guidance for industry and FDA staff. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm267829.htm. Accessed September 23, 2015.
7. OCallaghan K, Shuren J. Listening to patients views on new treatments for obesity. http://blogs .fda.gov/fdavoice/index.php/2015/01/listening-To-patients-views-on-new-Treatments-for-obesity/. Accessed September 9, 2015.