Bringing a medical device to market using clinical data acquired from an overseas trial could become more complicated in the near future if an FDA proposal becomes policy. In a bid to improve the quality of data that is being used to support 510(k) submissions, premarket approval applications (PMA), and investigational device exemptions (IDE), the … continue reading
Adaptive Trial Design Offers Advantages for Orphan Disease Research
So-called ‘orphan diseases,’ those which are estimated to afflict fewer than 200,000 individuals in the United States (with similarly low prevalence around the world) have long presented a challenge to drug researchers. Primarily, the issue has been one of locating an appropriately-sized sample population in order to conduct an effective clinical trial. Some rare conditions, … continue reading
Adaptive Enrichment Designs Stimulate Significant Interest Across Pharma
Pursuant to the FDA’s draft guidance on clinical trial enrichment strategies that was released at the tail-end of 2012, a growing number of drug companies are asking for the agency to provide examples of exactly how the recommendations made by the guidance can be implemented in real world practice. Specifically, industry players are looking for … continue reading
Harmonized Medical Device And Drug Regulatory Submissions Currently In Development
It would seem to make sense that cooperation between drug and medical device manufacturers could lead to enhanced efficiencies for the FDA. A harmonization effort, designed to marry the electronic submissions for both medical devices and drugs, is currently underway. This challenging task has been picked up by the International Medical Device Regulator’s Forum (IMDRF), … continue reading
Medical Device Companies Will See Changes Made to NCAR Program
Will medical device companies be looking at major changes to the National Competent Authorities Report (NCAR) program in the near future? NCAR was originally established 20 years ago in order to help facilitate the sharing of information concerning serious adverse events associated with medical devices in a confidential manner. Specifically, NCAR is used by a … continue reading
Egypt Streamlines Medical Device Regulations
Companies bringing a medical device to market in Egypt will need to familiarize themselves with recent changes being made by the Central Administration for Pharmaceutical Affairs (CAPA) to its regulatory standards. These alterations, which went into effect at the beginning of 2013, are designed to streamline the medical device approval process and make it easier … continue reading
European Medical Device Vigilance System Updated
In January 2013, new guidelines were issued by the European Commission that describe the European system for the notification and evaluation of Incidents and Field Safety Corrective Actions (FSCA) involving medical devices, known as the Medical Device Vigilance System. These guidelines cover the actions to be taken once the manufacturer or national competent authority receives information … continue reading
China To Streamline Re-Registration Medical Device Regulations
Re-registration of a medical device in the Chinese market should become easier in the near future, thanks to efforts being made by the China Food and Drug Administration to simplify the current re-registration process. Currently, medical device manufacturers must re-register within six months of the expiration of a product’s original registration certificate. The move is … continue reading
Adoption of Adaptive Design Trials on the Increase
The Tufts Center for the Study of Drug Development recently hosted and facilitated a senior executive roundtable in Boston to discuss the adoption and impact of adaptive clinical trial design. The event, supported by an educational grant from Aptiv Solutions, involved forty senior executives from a variety of cross-functional areas including clinical development, biostatistics, project … continue reading
Advamed MTLI Design & Analysis Challenges for Pediatrics and Rare Diseases
Designing and analyzing clinical studies for pediatric devices and for medical devices that treat or diagnose a rare disease or condition brings unique challenges for clinical researchers. For pediatric devices, sponsors need to consider patient size and body structure, level of activity, duration of use, device longevity, and long-term exposure to implanted materials. For rare … continue reading
