Reportable Values for Out-of-Specification Test Results

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

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

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

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

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

The company is recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules.