TY  - BOOK
AU  - Weinberg, Sandy
TI  - Guidebook for Drug Regulatory Submissions 
SN  - 9780470371381
U1  - 344.7304233 
PY  - 2009///
CY  - New Jersey
PB  - John and Wiley Sons, Inc.
N1  - Destined to become every regulatory director's essential desktop companion.rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines
ER  -