Newsletter | October 13, 2022

10.13.22 -- FDA User Fee Reauthorization: CBER A Clear Winner

New Podcast Episode
Featured Editorial
Industry Insights
Security Of Supply In Cell And Gene Therapy Manufacturing

With so many challenges in the manufacturing of cell and gene therapies, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these lifesaving drugs.

U.S. FDA Hoping To Spur More ANDA Presubmission Meetings During GDUFA III

The FDA believes conducting a presubmission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval. Dive into the many communication enhancements in GDUFA III.

Designing Successful Viral Clearance Studies

A review of studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.

CDMO Collaboration: Foundation For Sterile Injectable Product Success

Explore how a small or midsize biotech or pharma company developing sterile injectables can benefit from the experience and assistance provided by a CDMO.

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