Consulting

Consulting

The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage

Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those investigational devices might be covered not only to offset the cost of development, but also...

Consulting

Conducting Clinical Studies Under an Investigational Device Exemption

An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often, clinical studies are conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions...

Consulting

Is Your In Vitro Diagnostic Exempt from Investigational Device Exemption Regulations?

An investigational device exemption (IDE) allows an investigational device to be used in a clinical study for the purpose of collecting safety and effectiveness data.1 However, many in vitro diagnostic (IVD) devices are released from IDE regulations if certain criteria are met. In this blog post, we discuss how device studies are classified and explore...

Consulting

CMC Considerations for Pre-IND Meetings

The pre-IND meeting is an opportunity for highly productive interactions between sponsors and the FDA, allowing for discussion of key material attributes and development strategy plus requests for Agency review and advice on specific topics. In general, such meetings are multidisciplinary and cover the regulatory, Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical plans for...

Consulting

Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals: 2023 RAPS Article of The Year

Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks of nitrosamine contamination and potential...

Consulting

Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals: 2023 RAPS Article of The Year

Meet Our Speakers: Dr. Olu AlobaVice President, CMC Services Dr. Marianthi KarakatsaniDirector, CMC Development Strategy

Consulting

Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals: 2023 RAPS Article of The Year

October 19th, 202311:00 a.m. EDT Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks...

Consulting

Orphan Drug Designation: When Is It Appropriate, and How Does It Apply to Orphan Subsets?

It is an unfortunate reality that many diseases and conditions affect such small numbers of patients that, when a sponsor develops a drug or biological product to treat them, relatively little return on investment is generated to offset the high development costs. As a result, the pharmaceutical industry has neglected many rare diseases in the past. However,...

Development Strategy

Advancing from Research to Development: What Can Go Wrong?

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. With many steps in between, each as important as the next, multiple factors regarding development strategy and approach must be considered at the earliest stages. This blog post offers advice for...

Clinical Research: Phase 1 - Phase 4

Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines

Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of improvement in tumor response rates showed only 10 percent of these therapies...