On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2)…
On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2) format.…
The AAPS 2017 Annual Meeting & Exposition will be held in San Diego November 12-15. The exhibit hall will be open as follows: Monday November 13, 2017 10:30 AM – 5:00 PM Tuesday November 14, 2017 8:30 AM – 5:00 PM Wednesday November 15, 2017 8:30 AM – 1:30 PM CROs: come see us about…
According to Commissioner Gottlieb, “Each year, FDA receives over 1,000 applications for the treatment of patients through expanded access, also known as compassionate use, and the agency authorizes the vast majority (about 99%). FDA recognizes that time is critical for these seriously ill patients who do not have alternative therapies, and who cannot take part in a clinical…
Clinical Informatics News recently reported that “Real-world data sources are combining with traditional data sources—clinical trials, electronic medical records, genomic data, insurance claims, streaming connected devices, social media, meteorological data, and patient reported data—to offer a wealth of possible applications. And now maturing technologies like machine learning and algorithmic methodologies can make sense of these…
FDA recently announced a new platform to request pre-ANDA meetings. Because PDG spends a considerable amount of time on complex generic development, we enrolled on day one. Here’s a description, followed by a link to the full story from FDA: “On October 1, 2017, the FDA launched a new technology platform, which will allow industry…