Author: admin
USA
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs
The Food and Drug Administration (FDA or Agency) is announcing the availability...
Real World Evidence in Medical Device to Support Regulatory Decisions
Real-world evidence (RWE) refers to data regarding the use, effectiveness, and safety of medical products (such as drugs, biologics, and medical devices) that is derived from real-world sources, including...
Medical Devices – USA, Europe, Asia and ROW Regulatory News – Apr 2024
USA
FDA Data Standards Catalog Version 10.3
The FDA Data Standards Catalog listed the submission data standards for dependent properties i.e., technical document.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog
EUROPE
MDCG...
Consumer Health – USA/Europe/Asia/ROW Regulatory News – April 2024
USA
New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry
FDA published final guidance New Dietary Ingredient Notification Procedures and Timeframes. This guidance...
Consumer Health – USA/Europe/Asia/ROW Regulatory News – March 2024
USA
FSIS Guideline for Label Approval
This guideline is designed to help establishments determine whether their labels must be submitted to FSIS’ Labeling and Program Delivery Staff (LPDS) for...
Consumer Health News, Food Safety, FSIS Guideline, Health Regulations, Healthcare News, Labeling Guidelines, Regulatory Updates, Standards
Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – March 2024
USA
Three FDA Final Guidance’s on Electronic Submission of Safety Reports
Three FDA final guidance’s address electronic submissions for reporting adverse reactions — one for investigational...
BioPharma Industry, Global Regulations, Industry News, Pharma Insights, Regulatory Updates