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Dockets Entered On June 18, 2003 TABLE OF CONTENTS (Linked) | ||||||||||||
| Docket # | Title | |||||||||||
| 2003D-0228 | Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA | |||||||||||
| 2003D-0229 | Draft Guidance for
Industry on Continuous Marketing Applications: Pilot 2 b Scientific Feedback
and Interactions During Development of Fast Track Products Under PDUFA | |||||||||||
| 2003P-0278 | regulate recombinant
and any other previously unlicensed endotoxin detection tests for validation,
in-process and finished product endotoxin testing od drugs | |||||||||||
| 2003P-0279 | Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin | |||||||||||
| 2003P-0280 | apparent determination that a recombinanat endotoxin tests intended for endotoxin testing of human drugs and medical devices | |||||||||||
| CONTENTS | ||||||||||||
| 1986P-0218 | REUSE OF KIDNEY DIALYSIS DEVICES | |||||||||||
| BKG 1 | Number not used | Vol #: | 1 | |||||||||
| 1998P-0151 | Introduction Of Downed Cattle Into The Food Supply | |||||||||||
| C 6554 | Jill Andross | Vol #: | 280 | |||||||||
| C 6555 | Sandra Tompkins | Vol #: | 280 | |||||||||
| C 6556 | Bernard Coley | Vol #: | 280 | |||||||||
| C 6557 | Mrs. E. Amoroso | Vol #: | 280 | |||||||||
| C 6558 | Deborah L. Tork | Vol #: | 280 | |||||||||
| C 6559 | Betty J. Pritchard | Vol #: | 280 | |||||||||
| C 6560 | Glenda Brookins | Vol #: | 280 | |||||||||
| C 6561 | Angela Liberatoscioli | Vol #: | 280 | |||||||||
| C 6562 | Mr. & Mrs. David L. Fisher | Vol #: | 280 | |||||||||
| C 6563 | no signature | Vol #: | 280 | |||||||||
| C 6564 | Ted Gorzny | Vol #: | 280 | |||||||||
| C 6565 | Shirley Winnie | Vol #: | 282 | |||||||||
| C 6566 | Ti Harmony | Vol #: | 282 | |||||||||
| C 6567 | Virginia O. Ansbergs | Vol #: | 282 | |||||||||
| C 6568 | M. T. N. | Vol #: | 282 | |||||||||
| C 6569 | Christina | Vol #: | 282 | |||||||||
| C 6570 | Karen Caruso | Vol #: | 282 | |||||||||
| C 6571 | Sid Shapiro | Vol #: | 282 | |||||||||
| C 6572 | Janice Emich | Vol #: | 282 | |||||||||
| C 6573 | Susan M. Tamol | Vol #: | 282 | |||||||||
| C 6574 | Joyce Raby | Vol #: | 282 | |||||||||
| C 6575 | Carmel H. Forte | Vol #: | 282 | |||||||||
| C 6576 | Jennifer Stolulonis | Vol #: | 282 | |||||||||
| C 6577 | Yvonne Dunn Hall | Vol #: | 282 | ||||||
| C 6578 | Linda Bataille | Vol #: | 282 | ||||||
| C 6579 | Susan T. Scott | Vol #: | 282 | ||||||
| C 6580 | Susan A. Dunham | Vol #: | 282 | ||||||
| C 6581 | Joan M. Raymond | Vol #: | 280 | ||||||
| C 6582 | Patty Gosdlin, R.N. | Vol #: | 282 | ||||||
| C 6583 | Mrs. Emil (Lee) Morlock | Vol #: | 282 | ||||||
| C 6584 | Catherine I. Dichinson | Vol #: | 282 | ||||||
| C 6585 | Calista Force | Vol #: | 282 | ||||||
| C 6586 | Sue Van Horn | Vol #: | 282 | ||||||
| C 6587 | Mr. Herbert Fabrikant | Vol #: | 282 | ||||||
| C 6588 | Arline F. Frankowski | Vol #: | 282 | ||||||
| C 6589 | Ms. Kathryn Hert | Vol #: | 282 | ||||||
| C 6590 | Brenda Novak | Vol #: | 282 | ||||||
| C 6591 | Pat Curnow | Vol #: | 282 | ||||||
| C 6592 | Nancy Zearfoss, Ph.D. | Vol #: | 282 | ||||||
| C 6593 | Doris Pipus | Vol #: | 282 | ||||||
| C 6594 | Andrea Stout | Vol #: | 282 | ||||||
| C 6595 | Jane E. Smiley, D.V.M. | Vol #: | 282 | ||||||
| C 6596 | Ms. JoAnn Lanzilotti | Vol #: | 282 | ||||||
| C 6597 | Mr. Wright H. & Karen Wolf | Vol #: | 282 | ||||||
| C 6598 | Olympia Saint-Auguste | Vol #: | 282 | ||||||
| C 6599 | Mary Jeffrey | Vol #: | 282 | ||||||
| 2003D-0228 | Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA | ||||||||
| NAD 1 | FDA | Vol #: | 1 | ||||||
| 2003D-0229 | Draft Guidance for Industry
on Continuous Marketing Applications: Pilot 2 b Scientific Feedback and
Interactions During Development of Fast Track Products Under PDUFA | ||||||||
| GDL 1 | GUIDANCE | Vol #: | 1 | ||||||
| NAD 1 | FDA | Vol #: | 1 | ||||||
| 2003P-0278 | regulate recombinant and any
other previously unlicensed endotoxin detection tests for validation, in-process
and finished product endotoxin testing od drugs | ||||||||
| ACK 1 | HFA-305 to Cape Cod, Inc. | Vol #: | 1 | ||||||
| CP 1 | Cape Cod, Inc. | Vol #: | 1 | ||||||
| 2003P-0279 | Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin | ||||||||
| ACK 1 | HFA-305 to Jerussi Consulting, Inc. | Vol #: | 1 | ||||||
| CP 1 | Jerussi Consulting, Inc. | Vol #: | 1 | ||||||
| 2003P-0280 | apparent determination that a recombinanat endotoxin tests intended for endotoxin testing of human drugs and medical devices | ||||||||
| ACK 1 | HFA-305 to Cape Cod, Inc. | Vol #: | 1 | ||||||
| PSA 1 | Cape Cod, Inc. | Vol #: | 1 | ||||||
Page updated July 24, 2003 jb