Apples to Apples: Playing the Comparability Game in Biotherapeutics Development
Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk.
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Understanding FDA's Project Optimus
May 16, 2023
Project Optimus is an initiative from the FDA Oncology Center of Excellence led by Drs. Mirat Shah and Atik Rahman.The goal of the initiative is to educate, innovate, and collaborate with the oncology community- including companies, academia,...
4 min read
Regulatory Guidance Monthly Review - April 2023
May 9, 2023
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...
Regulatory Considerations for Biosimilars Development in the U.S.
May 3, 2023
The development of biosimilar products in the U.S. has progressed since the regulatory pathway was established as part of the Affordable Care Act. Since then, the number of active biosimilar development programs has risen steadily. The market for these...
Dedicated Regulatory Project Management
April 12, 2023
Drug developers hire regulatory consultants and CROs to help navigate the complex regulatory agency requirements and interactions throughout the development lifecycle. While most Sponsors understand the role of a Regulatory Strategist, fewer have...
4 min read
Regulatory Guidance Monthly Review - March 2023
April 5, 2023
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...
Bold Thinking that Delivers Results for RNA Therapies
March 24, 2023
Current advances in RNA-based therapies hold substantial promise in treating and preventing many human diseases and disorders through curing the disease, rather than treating the symptomology like traditional therapeutics.
CMC Pitfalls: From Benchtop to IND
March 22, 2023
Successfully transitioning from academic or bench-top production to manufacture clinical-grade material is not an easy feat. There are many factors new sponsors must consider when determining readiness to file an Investigational New Drug (IND) from a...
2 min read
FDA Introduces New Term "Nonclinical Tests" Signaling a Beginning, Not an End
March 16, 2023
For the past 60 years, US law has empowered the FDA to require that clinical trial sponsors submit data from “preclinical tests ” to prove their drug is safe enough to advance to testing in humans. At the close of last year, Food and Drug Omnibus Reform...
4 min read
Regulatory Guidance Monthly Review - February 2023
March 13, 2023
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...