Statistics is the science of data that are used to collect a representative sample from an unknown target...
Clinical Trials
Blood Test Supports Cancer Screening Use
A study published in Annals of Oncology reported that a blood test can successfully detect more than 50 types of...
Stability Testing of Pharmaceuticals and Supplements
Whether you are working on a prescription drug, over-the-counter (OTC) drug, or even a dietary supplement, stability...
Investigating Ketamine for Parkinson’s Disease
In May 2021, the FDA approved an Investigational New Drug (IND) application from PharmaTher Holdings Ltd., to proceed...
Aduhelm, an Accelerated Approval for Alzheimer’s
Alzheimer’s disease is the most common cause of dementia, especially in patients aged 65 and older1. Alzheimer’s...
Tibial Nailing Advancement for Bone Healing
Traditional practice for treating a broken tibia shaft utilizes a central nail with load-sharing capabilities to...
Regulating Cellular Therapy Products
Cell therapies are regulated as biologics under the Center for Biologics Evaluation and Research division of the FDA....
Developing Clinical Trials for Your Intended User
For the past few decades, the FDA has been attempting to increase the diversity of individuals participating in...
Clinical Decision Support Software
Clinical Decision Support Software is a tool that is utilized in making decisions for the diagnosis, treatment,...
Stem Cell Clinic Injunction
The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency...
FDA and Dietary Supplements
The $40 billion dietary supplement industry is still growing making it a market you may want to take advantage of, but...
Reclassification of Surgical Staplers
FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject...
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