In Brief: CeraMed OsteoGraf CS-300
This article was originally published in The Gray Sheet
Executive Summary
CeraMed OsteoGraf CS-300: P-15 peptide is described in initial draft labeling as a "peptide which mimics the cell binding region of collagen." The Jan. 19 issue of "The Gray Sheet" incorrectly reported that draft labeling does not reference cell binding. In addition, the OsteoGraf N-300 and CS-300 contain inorganic rather than organic bovine derived hydroxyapatite particles as previously reported...
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.