Resources
Critical Steps of Pharmaceutical Development
(DYH
checklist
)
FDA "Animal Rule"
FDA Guidance: 505 (b)
How to Prepare for an Important Meeting with Regulatory Authorities
(DYH guide)
ICH CTD Overview
MHLW
R
egulation
Overview of Statistical Significance
(the basics)
Following are links to a few documents and websites that we have found either to be useful or
interesting. As a matter of convenience, we have gathered them here.
Selected Documents
Selected Websites
Biospace
CDC Homepage
ClinicalTrials.gov
Drugs@FDA
EMEA Homepage
EMEA Human Medicines
FDA Guidance
FDA Homepage
NIH
Orange Book
PharmExec.com
PubMed
UK electronic Medicines Compendium (eMC)
World Health Organization (WHO)