2 min read
Home >
Blog
Blog | Veristat
Gain the latest insights and trends in clinical trials, patient recruitment, data analysis, adaptive design, regulatory submissions and approvals.
Sign Up Today
Regulatory Consulting (8)
3 min read
Regulatory Guidance Monthly Review - June 2023
July 6, 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...
The Influence of MDR’s Article 117 in the Marketing of Combination Products
July 5, 2023
The European Union Medical Device Regulation’s (MDR) Article 117 brings improved patient safety measures with new implications for manufacturers, as they must fulfill a significant set of additional requirements.
2 min read
How does Real-World Evidence Impact Medicinal Product Development in Europe?
June 21, 2023
Explore the growing role of Real-World Evidence (RWE) in the regulatory decision-making process for medicinal products in Europe. Learn how RWE is reshaping the development landscape, its potential benefits, and the challenges associated with its...
5 min read
Regulatory Guidance Monthly Review - May 2023
June 15, 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...
Apples to Apples: Playing the Comparability Game in Biotherapeutics Development
May 23, 2023
Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk.
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...