MEDIcept Insights
European Union Clinical Trials Regulation: Mandatory Deadline Approaching
Since 2004, clinical trials in the EU have been controlled by the European Union Clinical Trials Directive (EU-CTD). The directive was an attempt to standardize rules and enhance patient protections in clinical trials; however, its real-life implementation created...
Part 3 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
Part 3 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December In Part 2 of this series, we discussed FDA’s first proposed rule, “Protection of Human Subjects and Institutional...
Part 2 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA regulations with the Common Rule – Comment Period Extended until December
In Part 1 of this series, we discussed the basic summary of FDA’s two proposed rules involving human subject protections and IRBs, as well as the extension FDA made to allow for commenters to have more time to develop thoughtful responses to the proposed rules. Part 2...
Part 1 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
On September 28, 2022, FDA released two proposed rules aimed at amending some sections of its current regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Federal Policy for the Protection of Human Subjects—also known as the...
‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)
When it comes to the medtech space implementing the second half of a 19-point action plan from the Medical Device Coordination Group, it’s pretty much yellow – or slow – across the board. At least that’s the assessment by notified body BSI Group. The MDCG’s plan,...
International Group ICH Offers Detailed Protocol Template For Clinical Trials
In a recently released draft guidance document, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describes general protocol design principles and approaches used to develop relevant documents for clinical...