ASBMR SABRE Team Submits Full Qualification Plan to FDA for ...

ASBMR SABRE Team Submits Full Qualification Plan to FDA for Approval of Bone Mineral Density as a Surrogate Endpoint for Future Trials of ...

News Releases - American Society for Bone and Mineral Research

ASBMR SABRE Team Submits Full Qualification Plan to FDA for Approval of Bone Mineral Density as a Surrogate Endpoint for Future Trials of New Anti-Osteoporosis ...

ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to ...

Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full ...

FDA Issues Timeline for Determination on FNIH-ASBMR-SABRE ...

FDA Issues Timeline for Determination on FNIH-ASBMR-SABRE Application to Qualify BMD as a Surrogate Endpoint in Future Trials of ...

FDA Approves Biomarker Qualification Plan for the First Surrogate ...

The qualification plan submission was an accomplishment of the Study to Advance BMD as a Regulatory Endpoint (SABRE), or Bone Quality Project, ...

Dr. Ebeling's President's Report - June 23, 2022

This team, including ASBMR members Dennis Black, Mary Bouxsein and Richard Eastell, now plans to submit a Full Qualification Package based on this approved plan ...

Entera Bio Reports Key Milestone Relating to Oral PTH (1-34 ...

Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full ...

Entera Bio Reports Key Milestone Relating to Oral PTH

Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full ...

ASBMR e-News Weekly: June 23, 2022 Edition

This team, including ASBMR members Dennis Black, Mary Bouxsein and Richard Eastell, now plans to submit a Full Qualification Package based on ...

Entera Bio Announces Full Year 2023 Financial Results and ...

“We expect an update on the qualification process of SABRE and BMD as the surrogate endpoint for fracture in 2024. We view this as the final de- ...

Bone mineral density as a surrogate endpoint for fracture risk ...

Bone mineral density as a surrogate endpoint for fracture risk reduction in clinical trials of osteoporosis therapies: an update on SABRE.

Entera Bio Announces Key Regulatory Milestone for Oral

In November 2023 we issued a press release echoing ASBMR's announcement that SABRE had submitted its final qualification package to FDA for the ...

RCT results from the FNIH-ASBMR-SABRE project | Journal of Bone ...

Treatment with anti-osteoporosis drugs significantly and similarly reduced fractures in both subgroups (eg, odds ratio [OR] = 0.47 and 0.51 for vertebral ...

analysis from the FNIH-ASBMR SABRE project | Journal of Bone ...

Pre-treatment bone mineral density and the benefit of pharmacologic treatment on fracture risk and BMD change: analysis from the FNIH-ASBMR ...

Biomarker Qualification Program - FDA

The mission of the CDER Biomarker Qualification Program (BQP) is to work with external stakeholders to develop biomarkers as drug development tools.

Dr. Calvi's President's Report – January 25, 2024

This includes the publication of the Task Force on Clinical Algorithms for Fracture Risk report in JBMR® as well as a webinar in February. The ...

Biomarkers Consortium - Bone Quality Project - FNIH

The Bone Quality Team obtained FDA approval for its Letter of Intent ... Qualification Plan. This LOI was the first LOI ever approved for a surrogate ...

Clinical Special Session: Update on the Strategy to Advance BMD ...

Clinical Special Session: Update on the Strategy to Advance BMD as a Regulatory Endpoint (SABRE) for Clinical Trials.

securities and exchange commission - Inline XBRL Viewer

... FDA's EOP2 remarks and emerging data from the ASBMR-FNIH SABRE program. In ... qualification of the FNIH-BQP criteria and their guidance on the ...

Engage With FDA About Qualification During Biomarker Development

... staff through the Letter of Support Program. Biomarker ... Qualification Plan, and the Full Qualification Package. Specifically ...