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U.S. Department of Health and Human Services

About FDA

Personalized Medicine

Phase I

Description:Work collaboratively with FDA Centers to assure the appropriate regulatory oversight of therapeutics and diagnostics when their safety and efficacy are intimately tied to one another and develop guidance, Standard Operating Procedures (SOPs) and policies to promote effective regulation.

Accomplishment:CDRH has created a Personalized Medicine Program to address regulatory and policy issues around use of diagnostic devices to specifically guide therapy, and to promote use of novel technologies as clinical diagnostics. By completing an initial aim of the program, OIVD is now able to identify and track therapeutic in-vitro personalized medicine submissions within CDRH using within Center tracking software. Formal mechanisms to address Personalized Medicine issues between CDRH, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Office of Combination Products (OCP) have been drafted and efforts are being made to finalize the drafts. The Office has hired the allotted staff for CDRH's personalized medicine efforts and they are undergoing training. Going forward, these mechanisms enable CDRH to better collaborate with other FDA Centers to assure the appropriate regulatory oversight of therapeutics and diagnostics when their safety and efficacy are intimately tied to one another.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Establish processes for identifying and tracking therapeutic-in vitro diagnostic (IVD) personalized medicine submissions within CDRH

3/31/2010

Completed 3/31/2010

B. Draft formal mechanisms to address Personalized Medicine issues between CDRH, Center for Biologics Evaluation & Research (CBER), Center for Drug Evaluation and Research (CDER), and Office of Combination Products (OCP)

6/30/2010

Completed 6/30/2010

C. Hire the allotted staff for CDRH’s personalized medicine efforts

9/30/2010

Completed 9/30/2010

D. Establish processes identifying and tracking therapeutic-non-IVD diagnostics personalized medicine submissions within CDRH

12/31/2010

Completed 12/31/2010

Phase II

Description:The goals of phase II are: (i) to assure that safe and effective diagnostic products that are either innovative themselves or provide innovative uses reach the US public; (ii) to improve the use of therapeutics; and, (iii) to allow consumers and patients to understand their genomic information. An IVD companion diagnostic guidance will address questions related to companion diagnostic devices used with therapeutics products. A panel meeting on direct-to-consumer (DTC) genetic testing is planned to allow FDA to gain information from the public and from an expert panel about the regulatory approach(es) to those genetic tests that are being offered directly to consumers without a doctor's prescription.

Accomplishment:CDRH has published the draft Companion Diagnostics Guidance, defining an In Vitro Diagnostic (IVD) companion diagnostic. Publishing the draft guidance is a step to provide clarity for manufacturers of targeted therapies and corresponding diagnostics so that they can build FDA’s expectations into their development plans at an early stage. In addition, knowing that the FDA is recommending simultaneous review will help manufacturers identify the need for a companion diagnostic earlier in the therapeutic development phases, helping both products reach the market in a timely and safe manner. CDRH has received public comments on the draft Companion Diagnostic Guidance (after extending initial comment period), and has completed the analysis and internally addressed the comments that were received. This will enable moving forward towards publishing the finalized Companion Diagnostics Guidance. CDRH has planned, organized and held an Advisory Panel meeting on direct to consumer (DTC) genetic testing. This meeting enabled FDA to gain information from the public and from an expert panel about possible regulatory approaches to those genetic tests that are being offered directly to consumers without a doctor's prescription. CDRH summarized meeting discussions, and developed high level recommendations for this type of tests. Going forward, CDRH will build on this groundwork in order to allow consumers and patients to understand their genomic information.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Draft Companion Diagnostic Guidance

12/31/2011

Completed 1/15/2012

1. Draft Guidance signed off by CDRH

3/31/2011

Completed 3/31/2011

2. Draft Guidance published by June 30, 2011 with 60 day comment period

6/30/2011

Completed 6/30/2011

3. Comments analyzed and addressed internally

9/30/2011 (1)

Completed 1/15/2012

B. DTC genetic testing public meeting/recommendation formulation

12/31/2011

Completed 12/31/2011

1. Plan and hold advisory panel

3/31/2011

Completed 3/31/2011

2. Develop high level recommendations for public comments

8/30/2011

Completed 8/30/2011

3. Finalize high level recommendations

12/31/2011

Completed 12/31/2011

Footnotes

  • (1) Public comment period was extended until 9/30/2011

Phase III

Description:The goals of phase III are (i) to assure that safe and effective diagnostic products that are either innovative themselves or provide innovative uses reach the US public; (ii) to improve the use of therapeutics; and (iii) to allow consumers and patients to understand their genomic information. CDRH will work collaboratively with other Centers in FDA to assure the appropriate regulatory oversight of therapeutics and diagnostics when their safety and efficacy are intimately tied to one another.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Clear within CDRH the draft guidance on Companion Diagnostics

6/30/2012

Completed 8/31/2012

B. Clear within CDRH the final guidance on Research Use Only (RUO)

6/30/2013

On Track

C. Establish a framework for the review of submissions addressing genomic tests

12/31/2012

Completed 12/31/2012

D. Clear within CDRH the final guidance on Direct to Consumer Tests

12/31/2013

On Track

E. Clear within CDRH the draft guidance on co-development

12/31/2013

On Track

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.