Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
News|Articles|January 5, 2006
Schering-Plough Meets FDA Deadline for CGMP Improvements
Author(s)Pharmaceutical Technology Editors
Schering-Plough Meets FDA Deadline for CGMP Improvements
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Schering-Plough (Kenilworth, NJ,
According to the company, Schering-Plough completed all of the 212 significant steps and 30 validation actions required by the FDA, and is awaiting approval by the agency and third-party certification after an upcoming review process.
It has taken nearly three-and-a-half years for Schering-Plough to revalidate and work out deficiencies in their manufacturing plants that led to $500 million in fines and the suspension of approximately 70 products.
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This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
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