Featured Pharma Online Editorial
-
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.
-
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).
-
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.
-
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?
-
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.
-
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.
-
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.
-
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.
-
From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
5/7/2025
The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.
-
Addressing Human "Error" In Pharma Manufacturing
5/7/2025
Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.