The company is voluntarily recalling all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials due to misleading labeling and its status as an unapproved drug.

FDA Creates CDER Center for Real-World Evidence Innovation

By Susan Haigney

December 13th 2024

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

Head with bulb | Image Credit: ©ShpilbergStudios – stock.adobe.com

Enhancing Quality Through Training

By Susan Haigney

December 11th 2024

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Novo Nordisk Gains Manufacturing Sites from Novo Holdings and Novavax while EC Approves Catalent Acquisition

By Feliza Mirasol

December 11th 2024

The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

Steps Towards Demystifying Risk-Based Decision Making

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

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Steps Towards Demystifying Risk-Based Decision Making; Image: Dontree - stock.adobe.com

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