Search
Sharan Murugan
- 3 days ago
- 2 min
EC MDCG: Guidance on Clinical Evaluation of Orphan Medical Devices
The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...
6 views0 comments
Sharan Murugan
- Jun 23
- 2 min
European Commission: Health Technology Assessment -Guidance on Outcomes for Joint Clinical Assessments and Reporting Requirements
The European Commission has recently published two new guidance documents on Health Technology Assessment (HTA), dated June 13, 2024....
16 views0 comments
Sharan Murugan
- Aug 24, 2022
- 1 min
Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment
On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...
62 views0 comments
Sharan Murugan
- May 24, 2022
- 1 min
Q&A Guidance on Unique Device Identification system - Medical Device Coordination Group
On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...
18 views0 comments