Newsletter | April 29, 2024

04.29.24 -- Leverage The FDA's Expedited Programs To Address Genetically-Driven Diseases

Gene Therapy For Mitochondrial Disease: A Guide To Emerging Regulation

Gene therapy holds great promise for addressing the underlying cause of genetically-driven diseases, such as primary mitochondrial diseases (PMDs). Learn how the FDA's expedited programs, along with the efforts of innovative companies, are paving the way for the development of effective gene therapies to address PMDs.


Navigating The Fast-Expanding Medical Device Market In China

Navigating the intricacy of China's medical device regulatory landscape can be challenging. It's crucial to stay abreast of the evolving regulations, particularly those surrounding clinical evaluation reports (CERs). Learn how collaborating with experts can help to position your company to capitalize on this dynamic market.


The Top 10 Most Cited QSR Clauses In FDA FY2023 Medical Device Inspections

The FDA has intensified its oversight of medical device manufacturers, as evidenced by an increase in inspections and citations issued during FY2023, and design controls have emerged as a focal point for the FDA. By proactively addressing these deficiencies, manufacturers can ensure compliance with FDA regulations and prioritize patient safety.


Developing Your Human Factors Risk Assessment And Evaluating Critical Tasks

Human factors engineering (HF/HFE) is the subject of understanding and optimizing how people interact with technology by using psychology and engineering. Determining the appropriate critical tasks to be evaluated and assessed is crucial to the HF/HFE process and needs to be addressed with the appropriate risk-based approach.


Effects Of Annex 1 Revisions On Manufacturing Operations

The revisions to EU Annex 1 set the stage for the future direction of the pharmaceutical/biotechnology industry and serve as the blueprint for the strategies and policies implemented by the many companies in the U.S. Examine some of the key takeaways and interesting changes in Annex 1 for risk management and contamination control strategies.


Compliance Considerations For Emergency-Use Delivery Systems

Auto-injectors are typically the delivery device of choice for emergency medications, garnering increased scrutiny from regulatory bodies regarding their safety and effectiveness. Review the FDA reliability requirement for auto-injectors and how to overcome the significant challenge for developers and manufacturers to maintain compliance.