PDA Letter Article

Regulatory Submissions: No Longer Paper-Based

by Matthew M. Lowe, MasterControl

Last year, the U.S. FDA granted 22 novel drug approvals for conditions ranging from eczema and asthma to spinal muscular atrophy and certain types of ovarian cancer (1). New treatment options like these happen, in large part, due to faster and more efficient technology- driven clinical trials and approval processes.