Clinical trials involving gene therapies for the treatment of Central Nervous System (CNS) indications are some of the more complex in the field of gene and cell therapy (G&CT) development. During the lockdown, the Food and Drug Administration (FDA) released specific draft guidance titled, Human Gene Therapy for Neurodegenerative Diseases (ND). This guidance provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients.
May 2021
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 for both COVID-19 related and non-COVID-19 related programs in May 2021.
As we say goodbye to Mental Health Month in May and welcome Men’s Mental Health Month in June, there is no better time to check in with ourselves and each other.
Team Veristat Participate in Cycle for Survival 2021 - Virtually
For the past seven years, Veristat has participated in Memorial Sloan Kettering's Cycle for Survival, the movement to beat rare cancers. Founded in partnership with Equinox fitness club back in 2006, this ground-breaking research fundraiser celebrated its 15th anniversary in 2021 and has raised nearly three hundred million dollars for rare cancer research to date.
April 2021
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 for both COVID-19 related and non-COVID-19 related programs in April 2021.
March 2021
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 for both COVID-19 related and non-COVID-19 related programs in March 2021.
The COVID-19 pandemic has accelerated the clinical trial community’s quest to streamline its data-driven processes in order to find new and better ways to gain flexibility and efficiency throughout the clinical development continuum.
February 2021
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 for both COVID-19 related and non-COVID-19 related programs in February 2021.
January 2021
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 for both COVID-19 related and non-COVID-19 related programs in January 2021.
December 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 for both COVID-19 related and non-COVID-19 related programs in December 2020.