GUEST COLUMNISTS

• Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight

  Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

• Ask The Pros — The Latest In Downstream HCP Mitigation

  Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.

• How Is RIM Software Transforming Regulatory Compliance?

  Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

• Scaling Up Manufacturing? Here's Why You Need A CMC Specialist

  CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

• A Look At Elsa, The FDA's New AI Digital Assistant

  The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

• Bracing For The Impact Of The Federal Workforce Reduction

  The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

• Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements

  This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.