February 2005

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

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

With the new $94 million (€90 million) funding, the company will develop its pipeline of oral macrocycle drugs, nCycles, against validated biologic targets.

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The draft guidance document provides recommendations for complying with 21 CFR 211.110.

Under the agreement, the companies will advance development of IBI3009, Innovent’s ADC candidate, which has received IND approvals in the US, China, and Australia.