These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Removal of regulations regarding certification of drugs composed wholly or partly of insulin--FDA. Direct final rule.
    Journal: Fed Regist; 1998 May 13; 63(92):26694-9. PubMed ID: 10179341.
    Abstract:
    The Food and Drug Administration (FDA) is repealing its regulations governing certification of drugs containing insulin and making conforming amendments to other sections of its regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act. FDA is using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. Most of the amendments in this rule are a direct result of the repeal of the statutory certification provision. The remainder of the amendments repeal or update out-of-date, noncontroversial regulations dealing with insulin. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives significant adverse comments and withdraws this direct final rule.
    [Abstract] [Full Text] [Related] [New Search]