Newsletter | November 16, 2023

11.16.23 -- Understanding The FDA's Current Focus On REMS


Risk Tool Selection With ICH Q9(R1) In Mind

This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

Essential Elements Of Technology Transfer

The principles of an effective technology transfer can apply at every stage of the drug development life cycle for biotech companies of every size. Tech transfer programs are usually bespoke, but they share common essential elements. This article breaks them down.

Understanding The FDA’s Current Focus On Risk Evaluation And Mitigation Strategies

The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.

FDA Introduces Quality Management Maturity Program

The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.


Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics

Challenges exist when developing biologic drugs to be efficacious but safe. Novel analytical techniques, such as surface plasmon resonance, can help circumvent these issues and optimize development.


Fresenius Kabi Launches Tyenne, The First Approved Tocilizumab Biosimilar In The European Union

Samsung Bioepis & Organon Announce FDA Acceptance Of Sbla For Interchangeability Designation For HADLIMA (adalimumab-bwwd), A Biosimilar To Humira

Biosimilars Forum Supports Senate Finance Committee Legislative Discussion Draft Promoting Biosimilars


Disposable Pen For The Self-Injection Of Chronic Disease Medications

Targeting The Fast Lane With Optimized Viral Detection


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