Method Validation by Phase of Development: An Acceptable Analytical Practice

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

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

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

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

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.