Can FDA Reinvent Inspections

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

The European Union is discussing ways to reduce Europe’s over-reliance on imports of APIs.

In this episode of the Drug Solutions Podcast, industry experts discuss the challenges and advantages of the digitalization trend in the biopharma industry, with particular emphasis on the impacts to biomanufacturing.

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

Josh Hoerner, general manager of Purisys, provides his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.