International Conference on Harmonisation; Guidance on E11 Clinical Investigation of Medicinal Products in the Pediatric
Population; Availability. (15DEC00)
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The Guidance |
Draft Guidance for Industry on Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a));
Availability. (04DEC00)
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The Guidance |
Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in
Pediatric Patients; Technical Amendment. (06OCT00)
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Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting. (24AUG00)
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Joint Meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee and the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting. (22AUG00)
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Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (22AUG00)
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Joint Meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee With the Pregnancy Labeling
Subcommittee of the Advisory Committee for Reproductive Health Drugs; Notice of Meeting. (22AUG00)
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OC 189. Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee; Notice of Meeting. (22AUG00)
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Report to Congress on Pediatric Exclusivity; Request for Comments. (05MAY00)
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International Conference on Harmonisation; E11: Clinical Investigation of Medicinal Products in the Pediatric Population.
(12APR00)
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Pediatric Parenteral Multivitamin Products; Drug Efficacy Study Implementation; Announcement of Marketing
Conditions. (26JAN00)
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