Ther Innov Regul Sci. 2015 May;49(3):434-442. doi: 10.1177/2168479014558275.
Pre-Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products.
Therapeutic innovation & regulatory science
Hong H Vu, Anne R Pariser
Affiliations
Affiliations
- 1 Office of New Drugs, Rare Diseases Program, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
PMID: 30222408
DOI: 10.1177/2168479014558275
Abstract
INTRODUCTION: Prior studies suggested that holding preinvestigational new drug application (PIND) meetings with FDA has a positive effect on clinical development time (CDT).
METHODS: New product marketing applications submitted to FDA CDER during fiscal years 2008-2012 were assessed for whether a PIND meeting was held and, if so, a qualitative assessment of meeting content was performed.
RESULTS: Discussions contained in the PIND meeting minutes tended to reflect topics appropriate to an early phase of drug development, including chemistry, manufacturing, and controls (CMC) and safety topics (eg, nonclinical and clinical domains). Additionally, FDA commonly provided additional advice most often in the clinical and CMC domains. Applications for which a PIND meeting was held during drug development had shorter CDTs than those that did not.
CONCLUSIONS: This analysis showed the importance of early communication with FDA during development, and small companies with limited regulatory experience may gain the greatest benefit from early communication with FDA.
Keywords: FDA; drug approval process; orphan drugs; rare diseases
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