Regulatory and Standard Setting Organizations

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.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

The draft guidance document provides recommendations for complying with 21 CFR 211.110.