DRAFT AGENDA (revised 3/05/02)
FOOD
AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
ALLERGENIC
PRODUCTS ADVISORY COMMITTEE MEETING
March 15, 2002
Versailles I and II
Bethesda Holiday Inn
Bethesda, Maryland 20814
| 8:00 a.m. | Administrative
Remarks |
|
| 8:10 | Opening
Remarks Samuel Lehrer, Ph.D., Committee Chair |
COMMITTEE UPDATES (Open Session)
| 8:15 | Overview of the Division of Bacterial, Parasitic & Allergenic
Products (DBPAP) |
|
| Richard Walker, Ph.D., Division Director |
||
| 8:30 | Overview of the Laboratory of
Immunobiochemistry: Jay E. Slater, M.D., DBPAP, Laboratory Chief |
|
| 8:45 | Discussion |
|
| 8:50 | Research
Updates Jay E. Slater, M.D Ronald Rabin, M.D., DBPAP, FDA |
|
| 9:35 | Discussion | |
| 9:50 | Break |
|
| 10:05 | Particulates
in Allergen Extracts and Compliance Overview Jay E. Slater, M.D Teddi Lopez, OCBQ, FDA |
|
| 10:35 | Discussion |
|
| 10:50 | Reduction
of Possible Exposure to TSE Agents in Allergen Extracts Jay E. Slater, M.D |
|
| 11:05 | Discussion |
|
| 11:15 | Open Public Hearing |
|
| 11:45 | Lunch |
REGULATORY DISCUSSION TOPICS (Open Session)
| 12:45 p.m. | Considerations for the Regulation of Recombinant Allergens for
the Diagnosis and Treatment of Allergic Disease Jay E. Slater, M.D |
|
| 1:15 | Discussion | |
| 1:30 | Glycerol in
Allergen Extracts Jay E. Slater, M.D |
|
| 1:45 | Discussion |
|
| 2:00 | Open Public
Hearing |
CLOSED
SESSION
| 2:30 | Presentation and Discussion of Site Visit Report |
|
| 3:30 p.m | Adjourn |