MHRA Guidance On Clinical Trial Conduct During COVID-19 Pandemic
FDA UPDATES - For Sponsors with Products Intended to Treat Indications Other than COVID-19
In this unique time, with many health authorities, governments and pharmaceutical companies focused on the global pandemic and how to prevent, diagnose and treat COVID-19, it is important to remember the number of therapies currently in development or already approved for the multitude of other diseases affecting people worldwide. FDA has issued several press releases and guidance that affect Sponsors running or planning clinical studies, those planning marketing applications and those with products already on the market. We summarize here valuable information that is important for drug and biologic companies to be aware of as they continue to try to make these therapies available to patients.
FDA Guidance On Clinical Trial Conduct During COVID-19 Pandemic - 18 March 2020
February 2020
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 and approval. Below are the relevant links to updates provided in February 2020.
January 2020
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 and approval. Below are the relevant links to updates provided in January 2020.
December 2019
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 and approval. Below are the relevant links to updates provided in December 2019.
November 2019 Updates from FDA
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 and approval. Below are the relevant links to updates provided in November 2019.
An Interview with Kevin Hennegan, Senior Regulatory Strategist, Veristat
Understanding the Various Considerations for EDC Selection
An Interview with Kathleen Boruchowski, Director of Data Management, Veristat
October 2019 Updates from FDA
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 and approval. Below are the relevant links to updates provided in October 2019.