ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE
September 13-14, 2001
Opiate Analgesics
Tab 1: Introduction pdf
Tab 2: Agenda and Questions to the Committee pdf
Tab 3: Session 1: Opiate Analgesic Development and Use pdf
Tab 4: Pain Management Literature (Bibliography)* pdf
Tab 5: Session 2: Opiate Analgesic Use in Pediatric Patients pdf
Tab 6: Pediatric Guidelines
Federal Register Notice Docket No.
00N-0074, Additional Safeguards for Children in Clinical Investigations of
FDA-Regulated Products. April 24, 2001, Pages 20589-20600 [TXT]
[PDF] [PRE-PUB]
Frequently Asked Questions on Pediatric Exclusivity (505A),
The pediatric "Rule," and Their Interaction
htm
Federal Register Notice Docket No. 97N-0165,
Regulations Requiring Manufacturers to Assess the Safety and Effectiveness
of New Drugs and Biological Products in Pediatric Patients. December
2, 1998, Page 66631-66672 [TXT]
[PDF]
Guidance for Industry: Recommendations for Complying
With the Pediatric Rule (21CFR314.55(a) and 601.27(a)), 11/27/00
pdf
Guidance for Industry: Qualifying for Pediatric Exclusivity
Under Section 505A of the Federal Food, Drug, and Cosmetic Act, Revised,
September 1999 pdf
Title 45 Code of Federal Regulations Subtitle A (10-1-97
Edition) §46 pdf
Federal Register Notice Docket No. 92N-0165,
Specific Requirements on Content and Format of Labeling for Human
Prescription Drugs; Revision of ``Pediatric Use'' Subsection In the Labeling,
December 13, 1994 htm
Title 21, Code of Federal Regulations, §201.57 (4-1-00Edition) pdf
Tab 7: Session 3: Prescription Drug Abuse pdf
Tab 8: Labeling and Advertising Regulations pdf
Tab 9: Bibliography pdf
* Copyrighted material may be viewed at public reading room at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 during the hours 9:00 a.m. to 4:00 p.m., Monday through Friday, except for federal holidays.