Safety Problems Roil Pharma and FDA

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.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

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

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.