Research and Development


Petition to FDA Questions Trial of Naltrexone Implant in Prisoners

BioCorRX’s use of a naltrexone implant for addiction treatment in state prisoners and the homeless was brought into ethical question by a consumer advocacy group in a citizen petition urging the FDA to launch an investigation. Read More

HHS Inspector General: Smartphone App Won’t Violate Kickback Laws

The Health and Human Services inspector general has green-lighted a sponsor’s request to offer smart phones to poor patients so they can take an antipsychotic drug with an electric sensor. Read More

FDA Issues Guidance on Therapeutic Protein Immunogenicity Tests

The FDA released guidance for sponsors of therapeutic proteins on developing tests to assess immunogenicity during clinical trials. Read More

FDA Launches Initiative to Accelerate Opioid-Oriented Device Development

In a move to combat the opioid crisis, the FDA launched an “innovation challenge” to stimulate the development of medical devices… Read More

Wearable Fitness Monitors May Be Useful in Cancer Treatment, Study Says

Wearable fitness trackers — medical devices that monitor a person’s steps taken per day — could be useful tools for assessing and treating cancer patients, a University of Texas Southwestern study suggested. Read More

UK’s MHRA Flags Changes for Device Trials

The UK’s Medicines and Healthcare products Regulatory Agency is switching to a new application form for medical device trials beginning April 18 and has announced changes that devicemakers should implement immediately. Read More

FDA Expert Panel Considers Trial Designs for Neurological Devices

Most members of the FDA’s Medical Devices Advisory Committee panel on neurological devices said patient age should not be a consideration for inclusion in a clinical trial, but life expectancy should, and patients with less than one year of life expectancy should be excluded from studies. Read More

Sensors and Wearables Transform Trials But Challenges Remain, Experts Say

With a multitude of sensors, wearables and mobile devices becoming available for use in clinical trials, sponsors should conduct systematic comparisons before designing protocols, according to experts at the annual SCOPE conference, who presented the work they’ve done to demonstrate the value of using digital monitoring in their studies, as well as the obstacles they encountered. Read More

FDA Clarifies How to Get Feedback Prior to Marketing Submissions

The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More

NESTcc Selects 11 Projects for Medical Device Real-World Evidence Use Cases

In support of the FDA’s plan to increase the use of real-world evidence in medical device regulatory decision-making processes, the National Evaluation… Read More