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Revisions to the general safety requirements for biological products--FD. Direct final rule.
Fed Regist. 1998 Apr 20; 63(75):19399-403.FR

Abstract

The Food and Drug Administration (FDA) is amending the biologics regulations by adding "cellular therapy products" to the list of products excepted from the general safety test (GST) and by adding an administrative procedure for obtaining exemptions from the GST requirements for other biological products. FDA is taking this action because the GST may not be relevant or necessary for biological products, including cellular therapy products, currently in various stages of development. This direct final rule is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiative, and is intended to reduce the burden of unnecessary regulations on biological products without diminishing the protection of the public health. Elsewhere in this Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws this direct final rule.

MeSH

Biological ProductsDevice ApprovalEquipment SafetyGuidelines as TopicPolicy MakingUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10178869

Citation

"Revisions to the General Safety Requirements for Biological products--FD. Direct Final Rule." Federal Register, vol. 63, no. 75, 1998, pp. 19399-403.
Revisions to the general safety requirements for biological products--FD. Direct final rule. Fed Regist. 1998;63(75):19399-403.
(1998). Revisions to the general safety requirements for biological products--FD. Direct final rule. Federal Register, 63(75), 19399-403.
Revisions to the General Safety Requirements for Biological products--FD. Direct Final Rule. Fed Regist. 1998 Apr 20;63(75):19399-403. PubMed PMID: 10178869.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Revisions to the general safety requirements for biological products--FD. Direct final rule. PY - 1998/3/27/pubmed PY - 1998/3/27/medline PY - 1998/3/27/entrez SP - 19399 EP - 403 JF - Federal register JO - Fed Regist VL - 63 IS - 75 N2 - The Food and Drug Administration (FDA) is amending the biologics regulations by adding "cellular therapy products" to the list of products excepted from the general safety test (GST) and by adding an administrative procedure for obtaining exemptions from the GST requirements for other biological products. FDA is taking this action because the GST may not be relevant or necessary for biological products, including cellular therapy products, currently in various stages of development. This direct final rule is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiative, and is intended to reduce the burden of unnecessary regulations on biological products without diminishing the protection of the public health. Elsewhere in this Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws this direct final rule. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/10178869/Revisions_to_the_general_safety_requirements_for_biological_products__FD__Direct_final_rule_ L2 - https://antibodies.cancer.gov/detail/CPTC-GST+Mu1-6 DB - PRIME DP - Unbound Medicine ER -