Welcome to the launch issue of the Veristat Global Policy Insights newsletter!
Now that Solutions for Life Sciences (SFL) is part of Veristat, our team of Global Policy experts will deliver comprehensive insights into the latest updates and developments in pharma, biotech, and medtech globally and locally, on a quarterly basis.
FDA measures to support advanced therapies and orphan drugs
The FDA has launched a new pilot program on cell and gene therapies to facilitate more efficient clinical development and has opened a call for proposals for its Rare Disease Endpoint Advancement (RDEA) Pilot Program. Sponsors who are successfully accepted into the RDEA pilot will be given the opportunity to have interactions with FDA experts.
Addressing shortages and ensuring availability of devices in the EU
The EU is taking action to consolidate the European Health Union and strengthen the preparedness and response capabilities of the health crisis and shortage. Additionally, the European Commission is taking key steps to smoothen the implementation of In Vitro Diagnostics Regulation (IVDR) and the Medical Devices Regulation (MDR).
Recent developments in the EU, UK, and Switzerland
Stay informed with the latest policy updates in Europe, including the EU’s Global Health Strategy, revisions to the UK regulatory framework for medical devices and strategy, EU and Swiss relations, and key updates from Swissmedic and the Federal Office of Public Health. Learn more >
Recent developments in the US
Read the latest updates on medical devices in the US, draft guidance on data monitoring in clinical trials, the FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND), and final guidance for holders of an abbreviated new drug application (ANDA). Learn more >
Connect with us to keep up with the latest news, case studies, guides, and events designed to help pharma and biotech companies stay on top of trends and challenges arising in clinical development, regulatory affairs, and commercialization.
