ACRP appreciates the opportunity to provide the FDA with our comments on the Draft Guidance on Providing Information about Pediatric Uses of Medical Devices under Section 515A of the Federal Food, Drug, and Cosmetic Act, as this issue has a significant impact on our membership. The attached document provides detailed comments, suggestions, and recommendations on specific sections of the draft guidance.
Attachments:
Association of Clinical Research Professionals ACRP Comment Pediatric Medical Devices FDA-2013-D-0117
Title: Association of Clinical Research Professionals ACRP Comment Pediatric Medical Devices FDA-2013-D-0117
Association of Clinical Research Professionals (ACRP) - Comment
This is comment on Notice
Draft Guidance for Industry and Staff; Availability: Providing Information About Pediatric Uses of Medical Devices under the Federal Food, Drug, and Cosmetic Act
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Attachments:
Association of Clinical Research Professionals ACRP Comment Pediatric Medical Devices FDA-2013-D-0117
Title:
Association of Clinical Research Professionals ACRP Comment Pediatric Medical Devices FDA-2013-D-0117
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