TY  - BOOK
AU  - Weinberg, Sandy,
TI  - Guidebook for drug regulatory submissions
SN  - 9780470371381
AV  - KF 3885 .W430 2009
PY  - 2009///
CY  - Hoboken, NJ
PB  - Wiley
KW  - Drug approval
KW  - United States
KW  - Drug Approval
KW  - Drugs
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
N2  - Offers written guide for effective submisssion of documents for required regulatory views during drug development. Provides information on ht emost common types of submissions, including: Meeting Requestss, Orphan Drug Applications, Investigatory New Drug Applications, 505(b) NDAs, Abbreviated New Drug Applications and Annual Report. Explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submisssions processs over the near future. A chapter compares the FDA processs to the four other major regulatory environments of Canada, European Union, Japan and Australia
ER  -