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OCR Page 1 of 73AUG - 7 1997
COPY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NIF - 7
Food and Drug Administration
21 CFR Parts 200, 312, 314, and 601
[Docket No. 97N-0165]
RIN 0910-AB20
Regulations Requiring Manufacturers to Assess the Safety and
Effectiveness of New Drugs and Biological Products in Pediatric
Patients
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
SUMMARY: The Food and Drug Administration (FDA) is proposing new
regulations requiring pediatric studies of certain new drug and
biological products. Many new drugs and biological products
represent treatments that are, at least at times, the best
available treatment for children, but most of them have not been
adequately tested in the pediatric subpopulation. As a result,
product labeling frequently fails to provide directions for safe
and effective use in pediatric patients. The proposed rule would
attempt to partially address this lack of pediatric use
information by requiring that manufacturers of a limited class of
new drugs and new biological products provide sufficient data and
information to support directions for pediatric use for the
claimed indications, before or soon after approval.
Manufacturers of a limited class of marketed drugs and biologics
would also in compelling circumstances have to provide such data.
This proposed rule is part of a comprehensive effort to increase
the number of new drugs and biological products with clinically
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