Apples to Apples: Playing the Comparability Game in Biotherapeutics Development
Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk.
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Regulatory Consulting (7)
4 min read
Regulatory Guidance Monthly Review - April 2023
May 9, 2023
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...
Regulatory Considerations for Biosimilars Development in the U.S.
May 3, 2023
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...
Dedicated Regulatory Project Management
April 12, 2023
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
Regulatory Guidance Monthly Review - March 2023
April 5, 2023
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...
CMC Pitfalls: From Benchtop to IND
March 22, 2023
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
FDA Introduces New Term "Nonclinical Tests" Signaling a Beginning, Not an End
March 16, 2023
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
Regulatory Guidance Monthly Review - February 2023
March 13, 2023
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
European Medicines and Medical Devices: Future Trends
March 8, 2023
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
March 7, 2023
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...