New studies specifically planned or conducted to examine a safety issue should be des ...

All relevant clinical and non-clinical safety data will cover only the period of the ...

Other information: This section of PSUR shall include details about signals and Risk ...

Other information: This section of PSUR shall include details about signals and Risk ...

Actions taken in reporting interval for safety reasons: This section of PSUR shall in ...

Studies: This section of PSUR shall capture the brief summary of clinically important ...

Presentation of individual case histories: This section of PSUR shall include the ind ...

Estimated patient exposure: This section of PSUR shall provide the estimates of the s ...