05Jun
FDA Introduces New Platform Technology Designation Guidance
FDA has taken a landmark step to streamline the drug application process for biotechnology companies by issuing new guidance on platform technology designation. This initiative…
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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 pivotal role in approving innovative treatments that offer hope…
12Apr
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 revolutionary change across industries. Among the diverse applications of…
03Apr
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, with steady dealmaking and a resurgence in investor confidence.…
04Mar
Medical Device Clinical Trials: A Short Overview
Just like drugs, medical devices have to undergo a rigorous testing process, prior to the market launch, in order to test the accuracy and efficiency…
12Feb
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 comes in! From speeding up data processing to ensuring…
23Jan
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 to drug approvals. Read about the 5 crucial decisions…
15Nov
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 to handle them efficiently with adaptive EDC systems.
17Oct
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 medical interventions from Pfizer, Bristol Myers Squibb, CRISPR, etc.
