The following symbols are used to flag certain warning letters containing alleged violations of specific FDA regulations and policies of current interest:
BiMo - IRB, sponsor/monitor, CRO, clinical investigator issues
BSE - Bovine spongiform encephalopathy issues
CAPA - Corrective/preventive action
C-H - Complaint handling
Cal - Calibration
Comp/Soft - Computer software validation
Design - Design controls
DSHEA - Violations of Dietary Supplement Health & Education Act of 1994
DTC - Direct-to-consumer advertising
E-M - Environmental monitoring
F-B - Lack of fair balance in promotions
Lab - Labeling issues
MDR - Medical device reporting violations
NDA - Lack of new drug application
O-L Use - Off-label promotion
OOS - Out-of-specification outcomes
QC/QS - QC/quality systems deviations
S-HACCP - Violations of HACCP requirements for seafoods
Stab - Stability
Ster - Sterility
Val - Validation
Web - Internet promotion irregularities
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