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 During the lockdown, the Food and Drug Administration (FDA) released specific draft guidance titled, Human Gene Therapy for Neurodegenerative Diseases (ND).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.
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.