Featured Pharma Online Editorial
-
GDUFA And Facility Readiness: A New Era for Generic Drug Approvals
2/13/2025
2025 marks the midpoint of the current Generic Drug User Fee Amendments (GDUFA) III program, so it's a good time to refresh yourself with requirements and facility readiness.
-
FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program
2/10/2025
The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.
-
These Were FDA's Top Citation Issues For Data Quality In 2024
1/31/2025
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
-
2024 Trends In FDA Observations For Sterile Drug Manufacturers
1/30/2025
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
-
Top 10 Data Auditor Statistical Software Requests
1/27/2025
Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.
-
Addressing Blind Spots In Assuring Therapeutic Equivalence
1/14/2025
The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.
-
AI's Promising Role In Adverse Event Management Of Small Molecule Drugs
12/27/2024
By fostering a proactive, technology-driven environment, pharma manufacturers can ensure swift, accurate tracking of adverse events while advancing patient safety and meeting compliance standards.
-
Will FDA Finally Enforce DSCSA Interoperability In 2025?
12/26/2024
Two experts weigh in on the persistent problems surrounding the Drug Supply Chain Security Act and its upcoming enforcement deadlines.
-
Antibodies 2025: Venerable & Naked Or Complex & Multi-Specific?
12/19/2024
Antibodies are the biotherapeutic bulwark, the steadfast stalwart in not just oncology, but infectious and chronic inflammatory diseases as well. We consulted with a variety of antibody developers for insight into the challenges and opportunities antibody modalities face in the coming year and beyond.
-
Zero-Acceptance Sampling Can Protect Your Next Data Migration
12/13/2024
When migrating data in a GMP setting, verifying every record is impossible. A well-structured sampling approach can mitigate the risks and help with a smooth transition.