US industry takes issue with FDA's post-market failings claim
This article was originally published in Clinica
Executive Summary
AdvaMed is disputing a recent FDA study that found a high percentage of non-compliance with post-market studies, which are required as a condition for receiving product approval. "We feel that the characterisation of the medical device industry as being substantially out of compliance is both inaccurate and unfair based on the full facts," said Jeffrey Secunda, the association's associate vice-president for technology and regulatory affairs in a May 2 letter to the agency.
You may also be interested in...
Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line
The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Stakeholders Devise Six-Point Plan To Improve Cross-Border Clinical Trials
Sponsors need guidance on ethics requirements and clarity around national regulations to conduct cross-border clinical trials in the EU, a multi-stakeholder forum says.