Product Approvability Recommendations From FDA Advisory Committees: Inconsistently Sought, Indirectly Obtained

Author:

Gulfo Joseph V.,Briggeman JasonORCID,Gamie Asmaa

Funder

Initiative for Patient-Centered Innovation, Daniel and Martina Lewis Center for Healthcare Innovation and Technology, School of Pharmacy & Health Sciences, Fairleigh Dickinson University

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference10 articles.

1. Food and Drug Administration. About advisory committees: laws, regulations & guidance. https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/LawsRegulationsGuidance/default.htm. Published July 3, 2017. Accessed August 29, 2017.

2. Food and Drug Administration. Guidance for FDA advisory committee members and FDA staff: voting procedures for advisory committee meetings. https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125641.pdf,p, p. 4. Published August 2008. Accessed April 17, 2017.

3. Food and Drug Administration. Panel recommendation options for premarket approval applications. https://www.fda.gov/OHRMS/DOCKETS/ac/05/briefing/2005-4162b1_02_Panel%20Recommendation%20Options.htm. Published December 10, 2004. Accessed April 17, 2017.

4. Food and Drug Administration. Summary of changes to CDRH’s advisory committee process. https://www.fda.gov/advisorycommittees/committeesmeetingmaterials/medicaldevices/ucm208485.htm. Updated July 8, 2014. Accessed April 17, 2017.

5. Smith J, Townsend S, Singh N, Ma P. FDA advisory committee meeting outcomes. Nat Rev Drug Discov. 2012;11:513–514.

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