On December 08, 2014, US Food and Drugs Administration (FDA) issued draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” This guidance provides recommendations to sponsors on how to Continue reading
The US Department of Health and Human Services Department (DHHS) proposed a new rule with respect to Clinical Trial Registration and Results Submission. This proposed rule Continue reading
July 24, 2014. Another client has completed Learn@Regxia’s ICH GCP online training webinar, and we have received more great feedback! “Wow, this Continue reading
The most relevant change in the new Revision of the Declaration relates to the rights of vulnerable people. Differently than in previous versions, specific groups are Continue reading
For the first time ever, the new revision of the Declaration of Helsinki makes explicit mention that Continue reading
Another distinctive modification in this new revision is the expansion of considerations on vulnerable populations and their needs of specifically considered protection according to the case.
With respect to the Informed Consent Process, the Declaration preserves the essential principle that Continue reading
Part 2: General Modifications
In the October 2013 revision, some definitions and statements that affect the informed consent process are explained in more detail which undoubtedly is a consequence of the current progresses attained in the clinical development activity.
These re-definitions in the General Principles of the Declaration are aimed to improve the Continue reading
When finalized, the guidance for industry “Providing Regulatory Submissions in Electronic Format – Standardized Study Data” will specify and implement electronic submission requirements for study data contained in NDAs, ANDAs, certain BLAs, and certain INDs. This guidance’s requirements will also be applied to Continue reading
In an effort to increase the reliability, quality, integrity and traceability of electronic clinical data the FDA has finalized a draft guidance (Guidance for Industry: Electronic Source Data in Clinical Investigations) released in November of 2012. “The guidance provides recommendations to sponsors, CROs, clinical investigators and others involved in the capture, review, and retention of electronic source data”. Ideally this guidance will help Continue reading