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
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect safety and effectiveness data.[1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device
The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children. PREA requires new drug applications (NDAs) and biologics license
With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. Working to bring these valuable new therapies to patients, sponsors engaged in strategic development often approach Premier Consulting for
The number of approvals for combination products and 505(b)(2) applications has risen in recent years. Combination products consist of at least two constituent parts, each subject to its own statutory and regulatory requirements. Unlike fixed-dose combination therapies, which consist of drug-drug combinations, combination products can
As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Combination products can be either two or more active pharmaceutical molecules, combined to address different aspects of a health condition, or the combination
Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct… Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on, Studies to conduct, Indication and
With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage. In recent months, the COVID-19 pandemic has only accelerated the adoption of these technologies. While many digital health products are unregulated,
As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products and Bridging for Drug-Device and Biologic-Device Combination Products – were published in response to the 21st Century
Fueled by unprecedented medical, technological and social advancements of the past century, it should be no surprise that we are living longer than ever before. By 2030, more than one in four people in Europe and North America will be 60 years or older. And
A New Draft Guidance Provides In Vitro Diagnostic Device Requirements That May Impact Therapeutic Drug Trials Did you know that an assay used in a clinical trial designed to study an investigational drug may be considered an investigational In Vitro Diagnostic (IVD) Device, and therefore
The FDA just released a new draft guidance on developing fixed-dose combination antihypertensive products. While the clarification for industry is good, the strategy is not new to Premier Consulting. Gaining approval of a combination product that is made up of approved, single-entity drugs is achieved
Fixed-dose combination products (FDCs), or drugs containing multiple active ingredients, offer benefits to pharmaceutical companies and patients. For Pharma, creative matching of multiple APIs can open new markets, while for patients, FDCs can offer convenience and therapeutic benefits. Often, FDCs are composed of previously approved
