2015 February

  • Comment Period Extended for NPRM on ClinicalTrials.Gov

    • 02.12.2015

    The Department of Health and Human Services (HHS) is extending the public comment period for the Notice of Proposed Rulemaking (NPRM) on Clinical Trials Registration and Results Submission. The proposed rule was published on November 21, 2014 (79 FR 69566) with a deadline for public comments of February 19, 2015. The comment period is being […]

  • FDA Issues Guidance on Laboratory Developed Tests (LDT’s)

    • 02.12.2015

    Laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. […]

  • NIH Issues NPRM for ClinicalTrials.Gov

    • 02.11.2015

    In late November 2014, the National Institutes of Health issued the Notice of Proposed Rule Making (NPRM) and a revised NIH policy regarding the ClinicalTrials.Gov database