FDA Seeks Risk-Based Inspection Program

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

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

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

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.

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Treatments for autoimmune diseases, multiple cancers, and skin blistering have been recommended for marketing approval.