Question
Pharmaceutical Jurisprudence Question on Standard institutions and regulatory authorities
As per US FDA, NDA’s for new chemical entitles are classified as either :
A
‘P’ for product review or ‘S’ for standard review
B
“P’ for priority review or ‘S’ for standard review
C
‘P’ for product review or ‘S’ for safety review
D
‘P’ for priority review or ‘S’ for safety review
Answer
“P’ for priority review or ‘S’ for standard review
Explanation
Solution
The correct option is (B) : “P’ for priority review or ‘S’ for standard review