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A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
Business letters are the most formal method of communication following specific formats. They are addressed to a particular person or organization. A good business letter follows the seven C's of communication. The different types of business letters used based on their context are as follows, Letters of inquiry; Letters of claim/complaints
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
must hold a current, unrestricted practical/vocational nurse license in the United States or its territories and must have hospice and palliative licensed practical/vocational nursing practice of 500 hours in the most recent 12 months or 1000 hours in the most recent 24 months prior to applying for the examination.
A certificate of incorporation is a legal document/license relating to the formation of a company or corporation. It is a license to form a corporation issued by the state government or, in some jurisdictions, by a non-governmental entity/corporation. [1] Its precise meaning depends upon the legal system in which it is used.
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A letter of intent (LOI or LoI, or Letter of Intent) is a document outlining the understanding between two or more parties which they intend to formalize in a legally binding agreement. The concept is similar to a heads of agreement , term sheet or memorandum of understanding .
Fiscal sponsorship can enable projects to share a common administrative platform with a larger organization, thus increasing efficiency. In addition to legal status, sponsors can provide payroll, employee benefits, office space, publicity, fundraising assistance, and training services, sparing projects the necessity of developing these resources and allowing them to focus on programmatic ...
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