Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA.
Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Sean
S
Khozin
Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Meredith
M
Chuk
Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Tamy
T
Kim
Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Geoffrey
G
Kim
Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Richard
R
Pazdur
Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland 20993, USA.
Suranjan
S
De
Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland 20993, USA.
Sanjay
S
Sahoo
D003201:Computers / Q000592:standards* / Q000639:trends; D018795:Device Approval / Q000592:standards*; D017277:Drug Approval; D006801:Humans; D058028:Research Report / Q000592:standards* / Q000639:trends; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards* / Q000639:trends