2004N-0535 - Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
FDA Comment Number : EC2
Submitter : Ms. Allison Mueller Date & Time: 02/16/2005 07:02:52
Organization : Hoffmann-La Roche Inc.
Drug Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
MedWatch Form 3500a
Section G ALL MANUFACTURERS
Field 3 Report Source:

Recommend adding 'Solicited' and 'Spontaneous' check boxes in order to distinguish spontaneous reports from solicited reports.