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REMS Issues

• HDMA Comments to FDA on Transparency Initiative - December 2, 2011
• HDMA's Statement to FDA's Joint Advisory Committee Meeting on REMS - November 29, 2011
• HDMA Comments to FDA Regarding PDUFA 2012 on REMS - September 15, 2011
• HDMA Follow-Up Comments on the Class Wide REMS for Certain Opioids - October 18, 2010
• HDMA Response to FDA REMS Questions Regarding Reporting and Restricted Distribution - October 14, 2010
• HDMA Written Comments Following-Up on FDA's REMS Public Meeting - August 31, 2010
• HDMA Statement for the FDA REMS Public Meeting - July 27, 2010
• Cover Letter to HDMA Comments to FDA on the REMS for Certain Opioids - June 30, 2009
• HDMA Comments on the FDA REMS for Certain Opioids - June 30, 2009
• HDMA Comments on REMS Under FDAAA - September 22, 2008

Other FDA Activities

• HDMA Comments to OMB on Medication Guides - May 25, 2012
• HDMA Comments to FDA on Conditions of Safe Use to Expand Certain Prescription Drugs for Non-Prescription Use - May 7, 2012
• HDMA's Statement to FDA on Approving Certain Prescription Drugs as OTC under Conditions of Safe Use - March 23, 2012
• HDMA's Comments to FDA on Establishing Timeframes for Implementation of Labeling Changes - February 17, 2012
• HDMA Comments on FDA's Information Collection on MedGuides - February 8, 2012
• HDMA Comments to FDA on Retrospective Review of the Bar Code Rule - January 6, 2012
• HDMA Comments to FDA on Periodic Review of Existing Regulations under E.O. 13563 - June 27, 2011
• HDMA Comments on the Determination of System Attributes for the Tracking and Tracing of Prescription Drugs Notice - April 12, 2011
• HDMA Comments on FDA's Draft Bar Code Guidance Question and Answer #12 - November 8, 2010
• HDMA Comments on the Patient Medication Information - October 29, 2010
• HDMA Comments on FDA's Transparency Initiative - July 20, 2010
• HDMA Comments on the Unique Device Identifier - September 18, 2009
• HDMA Comments to FDA and OMB on MedGuide Paperwork Requirements - December 23, 2008
• HDMA Public Comments on the draft FDA Five-Year Plan for PDUFA Implementation - June 20, 2008
• HDMA Testimony at Joint FDA Advisory Committee Meeting on iPLEDGE - August 1, 2007
• HDMA Written Comments on Risk Minimization Action Plans (RiskMAPs) - July 27, 2007
• Distributors' Perspective on the Implementation of Risk Minimization Action Plans (RiskMAPs) - June 25, 2007
• HDMA Written Comments on Electronic Prescribing Information - June 22, 2007
• HDMA Testifies at FDA's MedGuide Hearing 6-13-07 - June 18, 2007
• HDMA Testifies on Electronic Prescribing Information Distribution - April 27, 2007
• Agenda for the FDA Public Hearing on Electronic Prescribing Information - April 27, 2007
• HDMA Comments on the Proposed NDC Rule - January 26, 2007
• HDMA Testimony on FDA's Proposed NDC Rule - December 11, 2006
• Patient Safety Implications on Implementation of the Current FDA-Mandated Medication Guide Program - June 27, 2006

Contacts
Anita Ducca
Vice President, Regulatory Affairs
703-885-0240
aducca@hdmanet.org