Featured Pharma Online Editorial
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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.
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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.
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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.
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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.
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Survey Findings: How Are IDMP Readiness Efforts Progressing?
12/13/2024
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.
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FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics
12/11/2024
FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.
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Count On Data Integrity Auditors Making These 10 Requests
12/9/2024
Every audit, however unique, requires confirmation that effective data integrity governance exists, supported by strong SOPs, proper validation, and regulatory adherence.
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Is The BIOSECURE Act The First Real Step Toward Reshoring?
11/22/2024
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
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How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials
10/25/2024
Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.
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What's Next After FDA's DSCSA Extension?
10/18/2024
Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.