The Latest Biotech Updates

Development of Therapeutic Protein Biosimilars – Can Startups Content with the “State of the Art” Standard?

Development of Therapeutic Protein Biosimilars – Can Startups Content with the “State of the Art” Standard?

Artificial Intelligence for Drug & Biological Products – Credibility of AI Models for Context of Use – The “Model Risk” Paradigm

Artificial Intelligence for Drug & Biological Products – Credibility of AI Models for Context of Use – The “Model Risk” Paradigm

FDA Issues Draft Guidance for Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics

FDA Issues Draft Guidance for Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

Artificial Intelligence and the Implications for Drug Manufacturers (FDA Discussion)

Artificial Intelligence and the Implications for Drug Manufacturers (FDA Discussion)

Clinical Trials – Protection of Human Subjects and the Role of Institutional Review Boards (IRB)

Clinical Trials – Protection of Human Subjects and the Role of Institutional Review Boards (IRB)

Clinical Research Organizations (CRO) – Patient Recruitment & Privacy Considerations

Clinical Research Organizations (CRO) – Patient Recruitment & Privacy Considerations