Regulatory Affairs

CDER Plans Pilot to Test Clinical Data Interchange Standard

The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data. Read More

Fallout Over Zolgensma Data Manipulation Spreads

Novartis is facing fresh scrutiny after a Swiss newspaper revealed on Sunday that an unnamed executive at the drugmaker sold nearly $1 million in company stock just weeks before news broke of the data manipulation surrounding Zolgensma, its $2 million spinal muscular atrophy treatment. Read More