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CLNR 515 Acronyms Week 6
CLNR 515 Acronyms Week 6
25
Health Care
Graduate
09/28/2008

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Cards

Term
RAC
Definition
1) Reviewer Affaris Committee
2) Regulatory Affairs Certification
3) Recombinant DNA Advisory Committee
Term
RTF
Definition
Refuse to File: letter sent by FDA when incomplete NDA or ANDA is filed. FDA will not review the application until complete.
Term
Rx
Definition
Prescription
Term
S&E
Definition
Safety & Efficacy
Term
SAE
Definition
Serious Adverse Event
Term
SE
Definition
Substantially Equivalent: comparison of a new devcie to a legally marketed predicate device. SE establishes S&E.
Term
SEC
Definition
Securities and Exchange Commission
Term
SID
Definition
Subject Identification
Term
SME
Definition
Significant Medical Event
Term
SMO
Definition
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
Term
SOP
Definition
Standard Operating Procedure
Term
SR
Definition
Significant Risk
Term
SRD
Definition
1) Single Rising Dose
2) Significant Risk Device
Term
SUD
Definition
1) Single Use Device
2) Sudden Unexpected Death
Term
SUPAC
Definition
Scale up and Post Approval Changes
Term
TK
Definition
Toxicokinetics
Term
UAE
Definition
Unexpected Adverse Event: An AE whose nature or severity is not described in the investigator's brochure or in the Package Insert
Term
USAN
Definition
United States Adopted Name: a nonproprietary designation for any compound used as a drug, established by negotiation between the manufacturer and the USAN council
Term
USC
Definition
United States Code
Term
USDA
Definition
United States Department of Agriculture
Term
USP
Definition
United States Pharmacopoeia
Term
VAERS
Definition
Vaccine Adverse Event Reporting System: provides a database management system for the collection and analysis of data from adverse events following vaccination
Term
VAI
Definition
Voluntary Action Inidicated: indicated on FDA form 483 following inspection.
Term
WHO
Definition
World Health Organization
Term
WL
Definition
Warning Letter: M ost serious post-audit letter, requires action within 15 days
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