1 min read
Chief Medical Officer Summit -CMO 360°
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
1 min read
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.
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
Human Gene Therapy for Neurodegenerative Diseases Draft Guidance for Industry (05 Jan 2021)
Download DRAFT Guidance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)
Read our latest news: Veristat Expands Biometrics Capabilities by Acquiring SQN Clinical
Register now for an upcoming webinar: How to Better Plan Your Virtual Clinical Trial
Learn how Veristat Supported Marketing Applications for 10% of all FDA Novel Drug Approvals in 2020
1 min read
Apr 9, 2024 Veristat Events
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
4 min read
Mar 22, 2024 Veristat Events
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...