2004N-0535 - Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
FDA Comment Number : EC1
Submitter : Dr. Margaret Chrymko Date & Time: 02/16/2005 07:02:44
Organization : Erie VA Medical Center
Federal Government
Category :
Issue Areas/Comments
GENERAL
GENERAL
Would like to see the MedWatch form changed so that the product section puts all the data about the individual product on one line--ie drug name, dose, frequency, route, dates of use, diagnsosis for use and event abated/reappeared after reintroduction--all on the same line. Suggest create a section that uses the full width of the page for this. Keep the form one page for drugs as in one of the samples. Don't mind the second page for medication devices. Forms, as the samples printed for me, are missing section identifiers--i.e. one form has "D. Suspect Products", the other one does not having anything in this area, etc. Would also like clear directions on what type of adverse drug reactions that FDA does and does not want to see--i.e. do you want to receive them based on outcome information in B.2.--? use this section for that purpose and add anothger category that helps identify new/unreported reactions for reporting? Thank you for the opportunity to comment.