IND Safety Reports and IRBs

HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...

FDA Announces ClinicalTrials.Gov Enforcement Action

FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements.  While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...

HRP Continues to Monitor the COVID-19 Situation

HRP Consulting Group continues to monitor the local, national and worldwide incidence of the coronavirus and the illness it causes, as well as any federal and/or state guidance. As such, please continue to visit our dedicated COVID-19 page as we will be updating our...