Public Comment Information

INFORMATION FOR PHARMACEUTICAL MANUFACTURERS

Thank you for your interest in the DERP Draft Products.
Below you will find two links both related the public comment. The first link will display the DERP protocol for public comment. 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.

Commenters must submit a comment within the web site comment process for any information submitted to be considered. 

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.

The second link will lead you to the drafts currently posted for public comment. There you will also find the public comment form required for comment submission. If you have any difficulty with the comment form or have questions about the protocol, please contact the Center.

Drafts for Public Comment

The Drug Effectiveness Review Project is committed to transparency of information. Comments received on draft reports will be made available to the public upon request.