Electronic Records Management Practices and Part 11

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

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

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

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.