TY  - BOOK
AU  - Weinberg,Sandy
TI  - Guidebook for drug regulatory submissions
SN  - 9780470371381
U1  - 344.7304233 22
PY  - 2009///
CY  - Hoboken, N.J.
PB  - Wiley
KW  - Drugs
KW  - Law and legislation
KW  - United States
KW  - Drug approval
KW  - Drug Approval
KW  - Drugs, Investigational
N1  - Includes bibliographical references and index; Ten rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions; PHR; phr
ER  -