FDA Posts PDUFA VII Meeting Minutes Centered on Sentinel, REMS Assessments
The FDA has released minutes from its meetings in early 2021 with industry on PDUFA reauthorization, discussions that focused on the agency’s Sentinel drug surveillance system and proposed Risk Evaluation and Mitigation Strategies (REMS) assessments. … [Read more...]
How to use digital platforms to engage with your customers
Article contributed to PharmaLeaders by Rachel Murray, Head of Partnerships, Fountain Partnership The last year has seen the Pharma industry propelled into the digital world in order to deliver clear communication to healthcare professionals and customers. Traditionally reliant on face-to-face communication, including selling, the Covid-19 pandemic has accelerated online … [Read more...]
Scaling Single-Use Liquid Dispensing from R&D to Automated Production
Article contributed to PharmaLeaders by Barbara Biller, President of intelliTECH, Inc., manufacturer of custom liquid fill and finish machinery that delivers precision results for regulated liquid filling environments. Easy production scale up and changeovers are possible with accurate, reliable liquid measurement and filling systems in complete kits that eliminate the need … [Read more...]
How Remote Technologies Augment the Role of Study Sites in Clinical Research
Article contributed by: Ed Ikeguchi, CEO AiCure The jobs of study sites in clinical research are difficult. Keeping patients engaged throughout the course of a trial is always challenging, particularly now during the COVID-19 pandemic. While numerous remote technologies exist to facilitate virtual patient visits or to monitor patient’s medication adherence and symptoms, they … [Read more...]