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USFDA Statement: New Patient Medication Information - Medication Guide for Patients
Yesterday (31 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research (CDER) proposed a new...
Sharan Murugan
Jun 1, 20231 min read
30 views
0 comments
Philippine FDA: Guidelines for Importation and Exportation of Finished Drug Products & Raw Materials
Last Friday (26 May 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines for the...
Sharan Murugan
May 28, 20232 min read
427 views
0 comments
DRUGWATCH: Off-Label Drug Use: What You Need to Know
Off-label drug use refers to the use of a medication in a way that has not been approved by the Food and Drug Administration. This can...
Sharan Murugan
May 28, 20231 min read
26 views
0 comments
Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document...
Sharan Murugan
May 28, 20232 min read
34 views
0 comments
USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints
Today (26 May 2023) the United States Food & Drug Administration released multiple guidances related to both drugs/biologics and medical...
Sharan Murugan
May 25, 20232 min read
12 views
0 comments
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center...
Sharan Murugan
May 25, 20232 min read
151 views
0 comments
USFDA Guidance: GASK in Drug & Biologics: Nonclinical Info & Slide Imaging in Nonclinical Toxicology
Earlier today (25 May, 2023) the United States Food & Drug Administration released two guidelines "Generally Accepted Scientific...
Sharan Murugan
May 24, 20232 min read
27 views
0 comments
Malaysia's Medical Device Authority: Guideline on Medical Face Mask and Respirator
Recently (19 May, 2023) Medical Device Authority (MDA) of the Ministry of Health Malaysia released an updated guidance on "Medical Face...
Sharan Murugan
May 23, 20231 min read
19 views
0 comments
Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement
Yesterday (23 May 2023) Switzerland's Swissmedic released two updated guidances one is "Export Certificates" guidance and another one is...
Sharan Murugan
May 23, 20232 min read
35 views
0 comments
South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template...
Sharan Murugan
May 21, 20231 min read
23 views
0 comments
Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)
Earlier today (21 May 2023) to ensure the importation and shipment of medical devices comply with rigorous standards, the Saudi Food and...
Sharan Murugan
May 21, 20231 min read
176 views
0 comments
USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...
Sharan Murugan
May 18, 20232 min read
24 views
0 comments
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
Earlier today (17 May 2023) the European Medicines Agency released an updated guidance document on "Good Practices for Industry for the...
Sharan Murugan
May 18, 20231 min read
52 views
0 comments
UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"
UK's Medicines and Healthcare Products Regulatory Agency (MHRA) this week (16,17 May 2023) released updated multiple guidances related...
Sharan Murugan
May 18, 20232 min read
44 views
0 comments
USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
This week (11 & 12 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...
Sharan Murugan
May 13, 20231 min read
52 views
0 comments
EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding...
Sharan Murugan
May 13, 20231 min read
79 views
0 comments
UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated "Guidance on the qualified...
Sharan Murugan
May 13, 20232 min read
74 views
0 comments
UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Notify the MHRA...
Sharan Murugan
May 13, 20232 min read
41 views
0 comments
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...
Sharan Murugan
May 9, 20231 min read
113 views
1 comment
Ireland's HPRA: Guidance on Reporting & Investigation of Quality Defects
Irelands Health Products Regulatory Authority (HPRA) released final guidance on "Reporting and Investigation of Quality Defects in...
Sharan Murugan
May 9, 20232 min read
89 views
0 comments