The development of biosimilar products in the U.S. has progressed since the regulatory pathway was established as part of the Affordable Care Act. Since then, the number of active biosimilar development programs has risen steadily. The market for these...
Drug developers hire regulatory consultants and CROs to help navigate the complex regulatory agency requirements and interactions throughout the development lifecycle. While most Sponsors understand the role of a Regulatory Strategist, fewer have...
4 min read
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...
Successfully transitioning from academic or bench-top production to manufacture clinical-grade material is not an easy feat. There are many factors new sponsors must consider when determining readiness to file an Investigational New Drug (IND) from a...
2 min read
For the past 60 years, US law has empowered the FDA to require that clinical trial sponsors submit data from “preclinical tests ” to prove their drug is safe enough to advance to testing in humans. At the close of last year, Food and Drug Omnibus Reform...
4 min read
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...
1 min read
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...
1 min read
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...
4 min read
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...