Due to a high workload volume and ensuring submissions are reviewed in a timely manner, CADTH is deferring the effective date of the following two CDR procedural revisions:

• The timing of CDR review team’s responses being provided to the manufacturer, and
• The revised CDR voluntary withdrawal procedure

The revised date for these two procedural changes coming into effect is now for all submissions and resubmissions targeting the May 2016 CDEC meeting (rather than April 2016) and onward.

Revised Procedure for Providing CDR Review Team’s Responses
Effective for all submissions and resubmissions targeting the May 2016 CDEC meeting and onward, manufacturers will be sent the CDR review team’s responses to their comments eight business days prior to the CDEC meeting. CADTH will forward the CDR review team’s responses to the manufacturer for information only.

Revised Procedure for Voluntary Withdrawal
Effective for all submissions and resubmissions targeting the May 2016 CDEC meeting and onward, manufacturers will have until 4:00 p.m. ET three business days prior to the CDEC meeting to voluntarily withdraw from the CDR process.

For more information, please click on the following link.