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1) Reviewer Affaris Committee
2) Regulatory Affairs Certification
3) Recombinant DNA Advisory Committee |
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| Refuse to File: letter sent by FDA when incomplete NDA or ANDA is filed. FDA will not review the application until complete. |
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| Substantially Equivalent: comparison of a new devcie to a legally marketed predicate device. SE establishes S&E. |
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| Securities and Exchange Commission |
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| Significant Medical Event |
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| Site Management Organization: a person that assumes, as an independnet contractor with the clinical investigator, one or more of the regulatory obligations of a clinical investigator |
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| Standard Operating Procedure |
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1) Single Rising Dose
2) Significant Risk Device |
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1) Single Use Device
2) Sudden Unexpected Death |
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| Scale up and Post Approval Changes |
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| Unexpected Adverse Event: An AE whose nature or severity is not described in the investigator's brochure or in the Package Insert |
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| United States Adopted Name: a nonproprietary designation for any compound used as a drug, established by negotiation between the manufacturer and the USAN council |
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| United States Department of Agriculture |
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| United States Pharmacopoeia |
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| Vaccine Adverse Event Reporting System: provides a database management system for the collection and analysis of data from adverse events following vaccination |
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| Voluntary Action Inidicated: indicated on FDA form 483 following inspection. |
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| World Health Organization |
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| Warning Letter: M ost serious post-audit letter, requires action within 15 days |
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