Regulatory Guidance Monthly Review - January 2021

January 2021 


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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.

 

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New FDA Guidance Documents:


Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency Guidance for Industry (19 Jan 2021)
Download FDA Guidance

Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency Guidance for Industry (15 Jan 2021)
Download FDA Guidance

COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity Guidance for Industry (13 Jan 2021)
Download FDA Guidance

IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators (04 Jan 2021)
Download FDA Guidance

 


New Draft Guidance Documents:

 

Human Gene Therapy for Neurodegenerative Diseases Draft Guidance for Industry (05 Jan 2021)
Download DRAFT Guidance

 


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

Biden’s day one regulatory freeze (21 Jan 2021)

Read Article on RAPS.org

Amid pandemic, EMA's 2020 authorizations ticked upward (21 Jan 2021)

Read Article on RAPS.org

EMA offers parallel Article 58, centralized authorization reviews (14 Jan 2021)

Read Article on RAPS.org

In 2020, all goal dates met for CDER's novel approvals (13 Jan 2021)

Read Article on RAPS.org


 

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