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Based on an online seminar presentation made in collaboration with TOPRA and Veristat, this article dives into the future of the European medicines and medical devices industry and the changes in legislation that are being prompted by the evolving...
Emergency Use Authorizations (EUA) are a mechanism that allows the U.S. FDA to facilitate the availability of medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) threats, including emerging infectious diseases such as...
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Sponsors developing drugs or biologics intended to prevent, diagnose, or treat a rare disease or condition should consider applying for the Orphan Drug Designation (ODD) program with the FDA. The FDA’s Orphan Drug Designation program is meant to...
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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
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Clinical and regulatory teams face increased pressure to drive uninterrupted progress across the clinical development pathway. These teams routinely benefit from the support of an external partner who can minimize the risks of failure and missed...
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Decentralized clinical trials (DCTs) are becoming increasingly popular to optimize patient engagement and retention. At the same time, making DCTs a successful reality for the most complex studies is considered difficult given the many logistical and...
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Did you know approximately 1 in 10 Americans are affected by a rare disease or condition according to the National Institutes of Health (NIH)? That’s 30 million people in the US, and similarly in the EU affected.Before 1983 in the US and 2000 in the EU,...
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GENESIS BIOMED recently interviewed Xavier Luria, former Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA), and now Veristat’s Vice President of Regulatory Affairs, Europe.
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The FDA and EMA offer expedited regulatory approval pathways to accelerate time-to-market for novel therapies intended to treat serious conditions and unmet medical needs. There are twelve special designations, many of which reduce clinical development...
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Effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market.