Public Comment Process
Information for Pharmaceutical Manufacturers
Thank you for your interest in the DERP Draft Products.
The comment process for Draft Products is meant to provide an opportunity to comment on the key questions and the report itself. It is not meant to be a second opportunity to submit a dossier. If dossiers are submitted during the comment process, they will not be included in the review. The protocol outlines the type of information that is useful when making comments on the draft key questions and draft reports.
We suggest reading the protocol before submitting public comments. We would like comments to be thoughtful and concise. To be considered, comments must be submitted within the web site comment process.
Your responses are limited to 25,000 characters in total. You may refer to tables, graphs and publications in your comments. Your web site comments must provide context for any separate submissions to the EPCs and Participating Organizations to better organize their review of your comments. If the EPC desires more detail, the commenter will be contacted.
Please submit only new information in the comment process. Submitting information we already have, such as the product label, is not useful.
Download Public Comment Protocol
If you don't have Adobe Acrobat (required to view above document), please click here to download.
