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.

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

Revised guidelines published by EMA and HMA update the rules on identification of commercially confidential information and personal data used in marketing authorization applications.