MEDIcept Insights
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In a recently released draft guidance document, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describes general protocol design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...
New FDA ‘TAP’ Pilot Wants To Help Companies Traverse ‘Valley Of Death’ By Streamlining The Product Clearance Process. First Up: Cardiovascular Devices
Makers of cardiovascular devices can navigate the dreaded “valley of death” for their unmarketed products by playing in an upcoming pilot program from the U.S. Food and Drug Administration (FDA) that will allow for earlier and more frequent engagement between...