Bloomberg, a leading financial news and data provider, has recently instructed Bitcoin exchange-traded fund (ETF) exchanges and issuers to submit...
The Federal Trade Commission (FTC) has recently announced a groundbreaking initiative to combat the rising threat of AI voice cloning....
A Comprehensive Approach to Introducing Medical Devices into the Indian Market: Insights from Operon Strategist The Indian healthcare industry has...
Sequana Medical, a Swiss medical device company, has recently announced that it has received Current Procedural Terminology (CPT®) III reimbursement...
Development and Assessment for Companion Diagnostic Products: A Comprehensive Q&A Document by CHMP Companion diagnostic products play a crucial role...
DA-1726 IND Application Submitted to FDA for Phase 1 Clinical Trial in Obesity Treatment Obesity has become a global epidemic,...
Timeframes for the Fast-Track Process for Digital Health Applications: BfArM Guidance The field of digital health has been rapidly evolving...
Understanding Clinical Data Standardization in Clinical Trials and its Importance for FDA Compliance: Insights from ProRelix Research Clinical trials play...
Why it may be beneficial to consider eliminating NAR’s Clear Cooperation Policy The National Association of Realtors (NAR) implemented the...
Milestone Pharmaceuticals, a biopharmaceutical company focused on developing innovative therapies for cardiovascular diseases, recently announced that its New Drug Application...
An Overview of the New Features in FDA eSTAR v5.0 The Food and Drug Administration (FDA) is constantly working towards...
Timeframes for BfArM Guidance on Fast-Track Process for Digital Health Applications: A Comprehensive Overview The field of digital health has...
CymaBay Therapeutics, a biopharmaceutical company focused on developing innovative therapies for liver and metabolic diseases, has recently announced its submission...
How to Plan for a Successful EMA Policy 0070 Submission The European Medicines Agency (EMA) Policy 0070 is a regulatory...
The FDA eSTAR Submission Template is an essential tool for companies seeking to gain approval for their medical devices or...