Featured Pharma Online Editorial

1. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

   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.

2. Navigating Data Management Requirements For Sterile Manufacturing 6/11/2025

   Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.

3. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

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

4. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

   The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

5. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

   Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

6. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

   The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

7. What Patients Say Matters: How AI Analyzes Sentiment to Improve Generic Drug Oversight 5/22/2025

   Employing multiple AI models to analyze public sentiment of generic drugs minimizes bias and enhances reliability. This makes AI a proactive tool for pharmaceutical quality assurance.

8. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

   The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

9. The 3 Phases of QRM – An Inspector's View 5/14/2025

   Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

10. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

    Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.