Blog | Veristat Insightful Perspectives

Regulatory Guidance Monthly Review - Dec 2021

December 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 December 2021.

 

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Regulatory Guidance Monthly Review - Nov 2021

November 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 November 2021.

 

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Regulatory Guidance Monthly Review - Oct 2021

October 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 October 2021.

 

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Regulatory Guidance Monthly Review - Sept 2021

September 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 August 2021.

 

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Regulatory Guidance Monthly Review - Aug 2021

August 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 August 2021.

 

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Part Two: Key Takeaways for Successful Development of Cell and Gene Therapies

As mentioned in part one of this blog, while the development of cell and gene therapy (C&GT) products has accelerated in recent years, even the best therapeutic may not reach patients who need it if study design and execution are not done correctly. It is important to put patient safety first, start communication with regulatory agencies early, and utilize an experienced team.

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Regulatory Guidance Monthly Review - July 2021

July 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 July 2021.

 

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Part One: Key Takeaways for Successful Development of Cell and Gene Therapies

Cell and gene therapy (C&GT) products are beginning to deliver on their long-hoped-for promise. CAR-T technology has proven to be a powerful new weapon in cancer treatment, and FDA approval of Luxturna in 2017 demonstrated the potential of gene therapies to be used outside of oncology. As both cause and consequence of this success, development and clinical trial activity in these product classes is accelerating. There are over 1,200 active clinical trials in regenerative medicine and advanced cell/gene therapies in 2021, up from 700 in mid-2019.

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Regulatory Guidance Monthly Review - June 2021

June 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 June 2021.

 

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Planning the Way Forward in Neurodegenerative Disease Studies

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.  

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