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 8, 2005
Warning Letter: Similasan
Warning Letter: Similasan
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On Aug. 16, The US Food and Drug Administration issued a
The agency’s concerns centered on filling processes and handling of sterilization filters. The letter cited “inadequate” heat-penetration studies of the filter autoclaving process and challenged the company’s practice of re-using filters up to 50 times without bacterial retention tests.
The agency was also concerned about the controls to prevent microbial contamination of sterile eye drops, the lack of written procedures to validate filling processes, and incomplete production and control information in the batch records.
–Douglas McCormick
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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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