In the PDUFA VII Commitment Letter, FDA announced its intention to roll out the Rare Disease Endpoint Advancement (RDEA) Pilot Program next year. This program is intended to address some of the unique challenges rare disease researchers face when determining endpoints...
In the PDUFA VII Commitment letter, the FDA announced the establishment of the Split Real-Time Application Review (STAR) Pilot Program. The goal of the STAR pilot program will be to decrease the time from the date of the complete submission to the PDUFA action date...
The Prescription Drug User Fee Act (PDUFA) VII, the 6th reauthorization of PDUFA, was signed by President Biden on September 30, 2022. In addition to the standard content that ensures the FDA has the necessary resources to provide a predictable and efficient review...
Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are innovating the clinical trial industry. It’s time for Sponsors to embrace accurate and efficient real-time electronic data collection directly from patients, in the...
CANTON, Mich. (10/2/2022) - Data anonymization and document anonymization in clinical trial data is now more important than ever. In recent years, clinical trial data sharing has become a requirement as part of the regulatory process for EMA and Health Canada. It is...
Augmented reality (AR) and virtual reality (VR) medical devices are being integrated into the medical field at an accelerating rate. On July 12th and 13th, 2022, the FDA held a Patient Engagement Advisory Committee (PEAC) meeting to consider the capabilities, risks,...
On 31 January 2022, the EU Clinical Trial Regulation 536/2014 (commonly known as EU-CTR) replaced the long-standing directive, the European Union (EU) Clinical Trial Directive 2001/20/EC (commonly known as EU‑CTD). There are important changes in the EU-CTR, compared...
Consultant – a person who provides expert advice professionally. Drug discovery and development is a team endeavor with significant expertise needed at every stage. This expertise is a challenge for any company to cover completely in-house. With drug discovery and...
Digital Health Technologies (DHTs) are rapidly innovating the health care and pharmaceutical industries. DHTs like mobile medical apps, wearable devices, telehealth and telemedicine have the potential to increase the focus on patients and enhance the delivery of their...