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|June 9, 2005
Warning Letter: C&M Oxyfill
Warning letter: C&M Oxyfill
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On May 26, the US Food and Drug Administration’s New Orleans, Louisiana, district office sent a
The cited CGMP violations include:
- failure to establish certain laboratory controls;
- failure to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment;
- failure to ensure that all production and control records were reviewed and approved by the quality control unit to determine compliance;
- failure to establish adequate batch production and control records for each batch of drug product produced.
In addition, the letter warned that the compressed oxygen cylinders manufactured by C&M are misbranded because the product’s labels do not have the required statement “Rx Only” prominently placed so it would be likely to be read and understood by an ordinary individual under customary conditions of purchase and use.
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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.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
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