FDA-speak : a glossary and agency guide

Contents......Page 9
Introduction......Page 10
Glossary
......Page 11
Appendix A Laws Enforced by the FDA......Page 279
Appendix B FDA Organization Charts and Contact Information......Page 282
Appendix C FDA Investigations Operations Manual......Page 287
Appendix D FDA Inspection Guides......Page 291
Appendix E Congressional Committees with FDA-Related Responsibilities......Page 294
Appendix F FDA Forms......Page 295
Appendix G CDER Guidance Documents
......Page 297
Appendix H CBER Guidance Documents......Page 321
Appendix I CDRH Guidance Documents ("Blue Book Memos")......Page 335
Appendix J CVM Guidance Documents......Page 339
Appendix K Food and Cosmetic Guidance Documents......Page 349
Appendix L DSMA Staff Directory......Page 364
Appendix M User Fees......Page 366
Acknowledgments......Page 371