Biomarkers and Precision Medicine Community (BPMC)

Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf

The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.

The impact on clinical trials and in general on patient care remains to be determined.

#fda #LDT #enforcement

Mark, thank you for flagging this for us. It's likely that this will impact clinical trials and patient care, much like what we've seen post the EU-IVDR rollout. Organizing an OSD on this matter could provide valuable insights. Would you consider being a panelist?  @Carmen Fernandez-Metzler; @Karen Quadrini; @Yanmei Lu; @Dale Miles could the BPM and GCTP community potentially co-host this event?

#fda #LDT #OSD

Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf

The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.

The impact on clinical trials and in general on patient care remains to be determined.

#fda #LDT #enforcement

Mark, thank you for flagging this for us. It's likely that this will impact clinical trials and patient care, much like what we've seen post the EU-IVDR rollout. Organizing an OSD on this matter could provide valuable insights. Would you consider being a panelist?  @Carmen Fernandez-Metzler; @Karen Quadrini; @Yanmei Lu; @Dale Miles could the BPM and GCTP community potentially co-host this event?

#fda #LDT #OSD

Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf

The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.

The impact on clinical trials and in general on patient care remains to be determined.

#fda #LDT #enforcement

Yan,

I was working with @Steven Piccoli and @John Allinson and have submitted this a few weeks back as a Hot Topic for PharmSci 360. We have an expert from Q2 (Patrice Hugo) and are working on having someone from the FDA for the panel discussion.  We are waiting to hear back on its acceptance. 

An OSD would be a great way to start the discussion.  I can certainly understand the implications of the new rule, but haven't waded through its 500+ pages yet.   It would be better I think to get someone who knows IVD submission process to comment on the activities of "GMP" or "GMP-like" practices needed for filing current and future LDTs under the new rule, as well as someone from CLIA labs who can assess the impact to current lab operations.

Mark, thank you for flagging this for us. It's likely that this will impact clinical trials and patient care, much like what we've seen post the EU-IVDR rollout. Organizing an OSD on this matter could provide valuable insights. Would you consider being a panelist?  @Carmen Fernandez-Metzler; @Karen Quadrini; @Yanmei Lu; @Dale Miles could the BPM and GCTP community potentially co-host this event?

#fda #LDT #OSD

Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf

The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.

The impact on clinical trials and in general on patient care remains to be determined.

#fda #LDT #enforcement

Agreed Mark and Yanmei.  Let's connect offline to plan this.  Thanks!

Yan,

I was working with @Steven Piccoli and @John Allinson and have submitted this a few weeks back as a Hot Topic for PharmSci 360. We have an expert from Q2 (Patrice Hugo) and are working on having someone from the FDA for the panel discussion.  We are waiting to hear back on its acceptance. 

An OSD would be a great way to start the discussion.  I can certainly understand the implications of the new rule, but haven't waded through its 500+ pages yet.   It would be better I think to get someone who knows IVD submission process to comment on the activities of "GMP" or "GMP-like" practices needed for filing current and future LDTs under the new rule, as well as someone from CLIA labs who can assess the impact to current lab operations.

Mark, thank you for flagging this for us. It's likely that this will impact clinical trials and patient care, much like what we've seen post the EU-IVDR rollout. Organizing an OSD on this matter could provide valuable insights. Would you consider being a panelist?  @Carmen Fernandez-Metzler; @Karen Quadrini; @Yanmei Lu; @Dale Miles could the BPM and GCTP community potentially co-host this event?

#fda #LDT #OSD

Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf

The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.

The impact on clinical trials and in general on patient care remains to be determined.

#fda #LDT #enforcement

Thank you @Mark Arnold for bringing up the topic!

For anyone who has not seen this yet the FDA is hosting a webinar on May 14th to discuss the final rule (https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024). They are accepting questions to be submitted before May 7th to be addressed at the webinar. 

Agreed Mark and Yanmei.  Let's connect offline to plan this.  Thanks!

Yan,

I was working with @Steven Piccoli and @John Allinson and have submitted this a few weeks back as a Hot Topic for PharmSci 360. We have an expert from Q2 (Patrice Hugo) and are working on having someone from the FDA for the panel discussion.  We are waiting to hear back on its acceptance. 

An OSD would be a great way to start the discussion.  I can certainly understand the implications of the new rule, but haven't waded through its 500+ pages yet.   It would be better I think to get someone who knows IVD submission process to comment on the activities of "GMP" or "GMP-like" practices needed for filing current and future LDTs under the new rule, as well as someone from CLIA labs who can assess the impact to current lab operations.

Mark, thank you for flagging this for us. It's likely that this will impact clinical trials and patient care, much like what we've seen post the EU-IVDR rollout. Organizing an OSD on this matter could provide valuable insights. Would you consider being a panelist?  @Carmen Fernandez-Metzler; @Karen Quadrini; @Yanmei Lu; @Dale Miles could the BPM and GCTP community potentially co-host this event?

#fda #LDT #OSD

Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf

The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.

The impact on clinical trials and in general on patient care remains to be determined.

#fda #LDT #enforcement

The College of American Pathologists (CAP) is also hosting a 1-hour discussion on this rule on May 23 at 11 AM ET/10 AM CT. 
Panelists will discuss:

·    Overview of the final rule
·    Timeline for implementation
·    CAP's recommendations adopted in final rule
·    CAP's LDT legislative advocacy efforts going forward
·    Q & A

https://www.cap.org/laboratory-improvement/regulatory-updates

Agreed Mark and Yanmei.  Let's connect offline to plan this.  Thanks!

Yan,

I was working with @Steven Piccoli and @John Allinson and have submitted this a few weeks back as a Hot Topic for PharmSci 360. We have an expert from Q2 (Patrice Hugo) and are working on having someone from the FDA for the panel discussion.  We are waiting to hear back on its acceptance. 

An OSD would be a great way to start the discussion.  I can certainly understand the implications of the new rule, but haven't waded through its 500+ pages yet.   It would be better I think to get someone who knows IVD submission process to comment on the activities of "GMP" or "GMP-like" practices needed for filing current and future LDTs under the new rule, as well as someone from CLIA labs who can assess the impact to current lab operations.

Mark, thank you for flagging this for us. It's likely that this will impact clinical trials and patient care, much like what we've seen post the EU-IVDR rollout. Organizing an OSD on this matter could provide valuable insights. Would you consider being a panelist?  @Carmen Fernandez-Metzler; @Karen Quadrini; @Yanmei Lu; @Dale Miles could the BPM and GCTP community potentially co-host this event?

#fda #LDT #OSD

Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf

The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.

The impact on clinical trials and in general on patient care remains to be determined.

#fda #LDT #enforcement