In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
Clinical Trials
EU MDR SSCP’s: The Importance of Readability
Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.
Avoiding Statistical Biases in Clinical Trials
Clinical trials, when conducted with great care, are the safest and fastest way in having a treatment approved for use to improve public health1. A clinical trial is an investigation conducted under a protocol which assesses the efficacy and safety of a treatment in humans.
Investigational Device Exemption
An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….
Statistical Sampling
Statistics is the science of data that are used to collect a representative sample from an unknown target...
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...
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