Search
Sharan Murugan
- Oct 25, 2023
- 1 min
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch...
19 views0 comments
Sharan Murugan
- Oct 23, 2023
- 1 min
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Enforcement Policy for...
17 views0 comments
Sharan Murugan
- Oct 23, 2023
- 2 min
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
A final guidance "Benefit-Risk Assessment for New Drug and Biological Products" was published last week (17 October, 2023) by the US Food...
24 views0 comments
Sharan Murugan
- Oct 21, 2023
- 2 min
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
Yesterday (20 October 2023) the European Medicines Agency released an updated guidance on "Procedural Advice for Orphan Medicinal Product...
28 views0 comments
Sharan Murugan
- Oct 21, 2023
- 1 min
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK
Last Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a...
37 views0 comments