In September 2017, the US FDA made public a draft industry guideline entitled “Statistical Approaches to Evaluate Analytical Similarity.” Its aim was to provide advice, to sponsors developing biosimilar agents, on how to demonstrate that the product under investigation is “highly similar” to the referenced biological. After taking into consideration the public comments relating to the document, the FDA withdrew the guideline in June 2018 for further evaluation and development to ensure that the scientific and regulatory issues that had been raised would be appropriately addressed. Continue reading “FDA to revisit guidelines for biosimilar development pathway”
Report: Pharmacovigilance Strategy Meeting, Boston, MA, USA November 2017
In less time than it took for me to travel to the meeting from New Zealand – the day was over! Hard to believe that within a short eight hours, 25 lively roundtables were conducted, two keynote speeches were delivered, and the panel discussed the learning of the day, including challenges of monitoring diverse sources, importance of real-world evidence in the context of risk benefit, and the game-changing impact of artificial intelligence. Continue reading “1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?”
Our partners Amplion recently published an interesting blog post on the benefits of biomarkers in informing earlier decisions in the drug development process – “fail early, fail fast” to save time and money, and increase approval success. An interesting read, check it out! Continue reading “Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers”
Colleagues from SpringerNature recently took part in the 3rd Annual Risk Management and Pharmacovigilance summit in Vienna, with the following meeting report provided by Daniela Ranzani, Adis Business Intelligence Product Manager.
Traditional topics as well as best practice and case-study presentations remain at the core of the meeting, allowing attendees to share knowledge and diverse experiences. Regulation revisions were also discussed, with a spotlight on the GVP Modules V and IX updates. Attention to patients with dedicated programs was highlighted, and a presentation on social media listening reminded us all of the great power represented by such tools when used for PV, which also brings great challenges in terms of carefully managing this type of information. Continue reading “Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna”