Health Canada

Regulatory Update, January 2016

Friday, January 1, 2016

FDA Seeks Comments on ICH’s GCP Guideline Update

In Sept. 29’s Federal Register, the FDA announced the availability of a draft guidance titled “Guideline for Good Clinical Practice” E6 (R2). The draft is an update of the International Conference on Harmonisation’s (ICH) “Guideline for Good Clinical Practice” E6 (R1), in which new information is integrated into the original document. The changes are intended to encourage improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also to update standards regarding electronic records and essential documents. The draft also is intended to improve clinical trial quality and efficiency while maintaining human subject protection. The FDA made the draft guidance available for public comment on the sections added to ICH E6 (R1) and marked as “ADDENDUM.”

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ASBM responds to Australia’s breaks with other regulators on biosimilar substitution

Wednesday, June 24, 2015

The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.

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BioPharma Services, Scentryphar partner

Wednesday, February 11, 2015

BioPharma Services (BPSI) has entered into a partnership and joint venture agreement with Scentryphar, a CRO located in Sao Paulo, Brazil. The partnership will support local and global sponsors looking to bring generic and innovative drugs to the Brazilian market by offering one-stop shopping and joint experience in clinical conduct, bioanalysis, data management, statistics and scientific and medical writing.

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Vital Connect, Medidata partner on continuous vital sign monitoring

Wednesday, December 10, 2014

Silicon Valley-based Vital Connect’s FDA-cleared wearable biosensor, HealthPatch MD, now is available for use in clinical trials in partnership with Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences. HealthPatch MD can be used with Medidata’s technology platform, Medidata Clinical Cloud, and its mobile app for patient-reported outcomes, Medidata Patient Cloud, to further remote patient monitoring, which has the potential to make clinical trials more efficient.

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