BioPharm International-08-01-2017

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.

Amid debate about “fake news,” peer-review papers offer vital, objective insight.

Improved resin chemistries and customized separation solutions are enabling more efficient separations.

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.

The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.

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