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21 st Century Citizen Pharma: The FDA & Patient-Focused Product Development.
- Source :
-
American journal of law & medicine [Am J Law Med] 2018 May; Vol. 44 (2-3), pp. 309-327. - Publication Year :
- 2018
-
Abstract
- Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration ("FDA"). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA's activity in drug, biologic, and medical device regulation over the course of the last one hundred plus years. The most recent fundamental reframing of the agency's authority and directive presented itself in the 21 <superscript>st</superscript> Century Cures Act, reflecting an important role for patient perspectives in the regulatory process. This Article explores recent developments in patient-focused product development efforts at the FDA and offers modest insights on the increasing role of patients, and patient advocacy groups, in agency decision-making. The Article terms this era "21 <superscript>st</superscript> century citizen pharma."
- Subjects :
- Compassionate Use Trials legislation & jurisprudence
Drug Development legislation & jurisprudence
Government Regulation
Humans
Regenerative Medicine legislation & jurisprudence
United States
United States Food and Drug Administration
Drug Approval legislation & jurisprudence
Health Policy legislation & jurisprudence
Medical Device Legislation
Patient Advocacy
Subjects
Details
- Language :
- English
- ISSN :
- 0098-8588
- Volume :
- 44
- Issue :
- 2-3
- Database :
- MEDLINE
- Journal :
- American journal of law & medicine
- Publication Type :
- Academic Journal
- Accession number :
- 30106644
- Full Text :
- https://doi.org/10.1177/0098858818789426