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
RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...
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
Veristat supported a Sponsor from SPA rejection to BLA submission, bringing strategic expertise to a small client team tackling their first clinical stage program for a novel ophthalmic therapy.
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...
1 min read
Were you able to join Veristat’s live webinar- “Strategies for Solving the Challenges of an Extraordinary Natural History Study – Navigating the Patient Experience When Pivoting to a Virtual Model Mid-Study”?
5 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...
2 min read
Each year, Veristat regulatory experts present timely, relevant topics to members of The Organization for Professionals in Regulatory Affairs (TOPRA), a UK-based organization committed to driving regulatory excellence across the healthcare regulatory...
3 min read
UPDATE – Veristat study collaboration with HIPRA leads to EMA approval of BIMERVAX® COVID-19 vaccine, the first bivalent recombinant protein vaccine to be authorized in the EU and the first human health vaccine to be designed and developed in Spain.
2 min read
The In Vitro Diagnostics Regulation (IVDR, EU 2017/746) enters into application in the European Union (EU) on 26 May 2022.