05Jun
FDA Introduces New Platform Technology Designation Guidance
FDA has taken a landmark step to streamline the drug application process for biotechnology companies by…
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Tag: FDA
29Apr
Innovating Healthcare: New FDA Approvals in 2024
In the clinical research industry, every year brings forth remarkable advancements and breakthroughs. FDA plays a…
Read More12Apr
Limitations of LLMs in Clinical Trials & How to Successfully Overcome Them?
The advent of artificial intelligence, NLP, GenAI, and large language models (LLMs) have brought in a…
Read More03Apr
Crucial FDA Decisions for the Second Quarter of 2024
The life sciences industry has embarked on a promising journey in the early months of 2024,…
Read More04Mar
Medical Device Clinical Trials: A Short Overview
Just like drugs, medical devices have to undergo a rigorous testing process, prior to the market…
Read More12Feb
Fundamentals of Understanding SDTM in Clinical Trials – Part I
Keeping data organized and reliable is crucial to the success of clinical trials. That's where SDTM…
Read More23Jan
5 Crucial FDA Decisions to Look Out for in 2024’s Quarter 1
FDA is anticipated to make some key decisions in the first quarter of 2024 with regards…
Read More15Nov
Mid-study Changes and Their Impact on Clinical Trials
Mid-study changes pose a great challenge to outcomes of clinical trials. Though necessary, it is important…
Read More17Oct
Crucial FDA Decisions to Look Out For in Late 2023
FDA is going to make some significant decisions with respect to approval of a few life-changing…
Read More23Aug
Dataset-JSON Might Replace XPT in Clinical Trials Industry Soon!
CDISC has kickstarted an FDA pilot program, jointly with PHUSE to replace the XPT format with…
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