Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee

 

Food and Drug Administration

Center for Drug Evaluation and Research

Hilton, The Ballrooms, 620 Perry Parkway, Gaithersburg, MD.

 

Clinical Risk Management of HPA Axis Suppression in Children

with Atopic Dermatitis being treated with Topical Corticosteroids

 

 

Draft Agenda for October 29, 2003

 

8:00         Call to Order, Introductions:                                                      Joan P. Chesney, M.D., Chair

 

                Meeting Statement:                                                                            Thomas H. Perez, R.Ph., M.P.H.

Executive Secretary

 

Opening Comments:                                                                           Dianne Murphy, M.D.

Director, Office of Counter-terrorism and Pediatric Drug Development

                                                                                                                                                     and

                                                                                                                                Jonathan Wilkin, M.D.

                                                                                                                                Director, Division of Dermatologic

                                                                                                                and Dental Drug Products

 

8:30         Atopic Dermatitis:  Its Clinical Course                                   Bindi Nikhar, M.D.

                and Therapeutic Options                                                                  Division of Dermatologic and

Dental Drug Products

 

9:00                Overview of HPA Axis Suppression                                         Jean Temeck, M.D.

                                                                                                                                Division of Pediatric Drug

Development

 

9:40         FDA Experience:  Topical Corticosteriods                                    Denise Cook, M.D.

                and HPA Axis Suppression                                                                Division of Dermatologic and

Dental Drug Products

 

10:10       Post Marketing Adverse Event Reports                                  ODS Staff

 

10:20       Q & A of Speakers

 

10:35       Break

 

10:50                Discussion of Question 1

 

11:10                Framework for Risk Assessment and Management                Anne Trontell, M.D.

                                                                                                                                Office of Drug Safety

 

11:30       Q & A of Speakers                                                                         

 

11:45       Lunch

 

12:45       Open Public Hearing

 

1:45                Discussion of Questions 2-4 and Wrap Up

 

3:30         Break

 

Section 17, Best Pharmaceuticals for Children Act, Adverse Event Reporting

 

3:45         Adverse Event Reports per Section 17 of BPCA                    Solomon Iyasu, M.D.

                                                                                                                                Division of Pediatric

Drug Development

 

4:30         Open Public Hearing

 

5:00                Committee Discussion of Presentations

 

5:30         Adjourn