One question we hear regularly from emerging biotechs is: Do we really need a formal Target Product Profile right now? Like many good answers to regulatory questions, “it depends.” A great TPP that is grounded in data and stra...
Regulatory
Access comprehensive insights on regulatory strategies and updates from Facet Life Sciences, guiding your path to compliance and approval.
Why Separating Regulatory and Commercial Strategy Can Kill an Otherwise Promising Biotech
For many small biotech teams, regulatory and commercial strategies are treated as sequential activities: first secure FDA approval, then figure out how to sell the product. Chronologically, that seems reasonable. Strategically,...
How Do I Determine Good Regulatory Guidance?
by Lisa Jenkins VanLuvanee, Ph.D. For small biotech and medical device companies without internal regulatory experts, knowing whether you’re getting the right advice can be a real challenge. In this interview, Dr. Lisa Je...
Everyone is Talking About HEOR! What Exactly is it and Why is it Relevant to You?
By Dr. Randy Goodman Ph.D., MHA, FACHE, PMP, BCMAS HEOR stands for Health Economics and Outcomes Research. It is a science that combines health economics, which focuses on the allocation of healthcare resources, and outcomes re...
FDA Nonclinical Requirements for Radiopharmaceutical Drugs: Diagnostic vs. Therapeutic Pathways
By Dr. Bill F. Hodnick, DABT If you are developing a radiopharmaceutical drug and preparing for an Investigational New Drug (IND) filing, understanding nonclinical requirements set by the Food and Drug Administration (FDA) is e...
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