• Federal register · Apr 1993

    Delegations of authority and organization; Center for Drug Evaluation and Research--FDA. Final rule.

    • Fed Regist. 1993 Apr 1; 58 (61): 17093-4.

    AbstractThe Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to the approval of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and their supplements to add the Deputy Director (Medical and Scientific Affairs), Center for Drug Evaluation and Research (CDER), to the list of officials authorized to approve certain NDA's, ANDA's, and their supplements for drugs for human use. In addition, FDA is adding authority to approve applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (505(b)(2) applications) to these officials. These authorities were given to FDA under section 505 of the act.

      Pubmed     Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…