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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.
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New Draft Guidance Documents:
Human Gene Therapy for Neurodegenerative Diseases Draft Guidance for Industry (05 Jan 2021)
Download DRAFT Guidance
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)
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Read our latest news: Veristat Expands Biometrics Capabilities by Acquiring SQN Clinical
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Register now for an upcoming webinar: How to Better Plan Your Virtual Clinical Trial
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Learn how Veristat Supported Marketing Applications for 10% of all FDA Novel Drug Approvals in 2020
- Download our COVID-19 Guide on Strategies For Success During the COVID-19 Era
- Read our infographic to Understand FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER