Format

Send to

Choose Destination
Clin Pharmacol Ther. 2010 Jan;87(1):27-31. doi: 10.1038/clpt.2009.179.

Expediting patients' access to medicines by improving the predictability of drug development and the regulatory approval process.

Author information

1
Centre for Medicines Research International Institute for Regulatory Science, London, UK. lliberti@cmr.org

Abstract

Ideally, well-designed global pharmaceutical development programs that include simultaneous submissions to multiple regulatory agencies can result in predictable regulatory approvals and expedited access to medicines for all patients. The workshops described herein investigated current trends in development and submission strategies along with regulatory review performance data in order to consider whether barriers to predictable expedited approval outcomes can be overcome through innovative clinical development approaches and a better understanding of review processes and procedures, particularly as these relate to the assessment of a product's risk-benefit profile.

PMID:
20019699
DOI:
10.1038/clpt.2009.179
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Wiley
Loading ...
Support Center