Revisions to the General Safety Test Requirements for Biological Products
other · Food and Drug Administration · Rule · Published 1998-08-05 · Effective 1998-09-02 · 63 FR 41718
Document
Document number
98-20823
Federal Register citation
63 FR 41718
CFR reference
21 CFR 610
Type
Rule
Action
Direct final rule: Confirmation in part and withdrawal in part.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-08-05
Effective date
1998-09-02
HHS docket
Docket No. 97N-0449
Abstract
The Food and Drug Administration (FDA) is confirming in part and withdrawing in part the provisions in the direct final rule that published in the Federal Register of April 20, 1998, to revise the general safety test (GST) requirements for biological products. FDA is confirming the part of the rule about which no significant adverse comment was received and withdrawing the part about which significant adverse comment was received.