This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
News|Articles|September 2, 2004
- Pharmaceutical Technology-09-02-2004
- Volume 28
- Issue 9
Promoting Quality in Drug Manufacturing
Author(s)Jill Wechsler
FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.
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In the Spotlight-September 2004about 22 years ago
Automation in a Digital, Webbed, and Wireless Ageabout 22 years ago
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Design of an Aseptic Process Simulationabout 22 years ago
Early Development Still Driving CRO Performanceabout 22 years ago
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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.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
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.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
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