Regulatory and Standard Setting Organizations

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

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

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

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

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.