The international Banff classification is commonly used by physicians to analyze biopsies of the transplanted kidneys. This is used to diagnose the rejection of kidney transplants; however, this classification has become more complex which leads to variability in its application and misclassification. These misclassifications can lead to physicians failing to modify or incorrectly modify the treatment regimen to protect the patient.
Recognized Consensus Standards
Under FDA compliance, to bring a medical device to market, there are a multitude of regulations that need to be accounted for and followed. Many of these regulations fall under the Code of Federal Regulations (CFR), however, others are known as recognized consensus standards. These recognized consensus standards are adopted from the International Organization for Standards (ISO), Clinical & Laboratory Standards Institute (CLSI), American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI), Association for the Advancement of Medical Instruments (AAMI), International Electrotechnical Commission (IEC), or other Standards Development Organizations (SDOs). These standards can either be voluntary or required via being ‘incorporated by reference’ into the regulation (CFR) .
Complex Innovative Trial Design
The FDA has recently been putting a much greater emphasis on working smarter not harder when conducting clinical trials. Types of clinical trial designs called Complex Innovative Trial Designs (CIDs) which come in response to the rapidly changing drug development environment have recently been getting a lot of attention. These designs allow clinical trials to answer more questions in less time.
The IND Process: An Overview
Prior to drugs being commercially available, manufacturers often conduct pre-clinical studies to obtain data ensuring that their drug is both safe and effective. Once the data has been collected, manufacturers then submit an Investigational New Drug Application (IND) to the Department of Food and Drug Administration (FDA). Per the FDA, “An IND is a request from a clinical study sponsor to obtain authorization from the FDA to administer an investigational drug or biological product to humans”.
Record Control for a Regulated World
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.”
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….
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...