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September 2023 Newsletter

Safe Biologics

View the full webinar here or watch individual segments linked below. 6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. Financing additional research and development into existing treatments will be difficult to justify. However, S.6

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October 2023 Newsletter

Safe Biologics

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Watch clips from the webinar here.

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Patient Engagement in Pharma – Why and How?

Viseven

The traditional model of drug development and healthcare delivery is undergoing a seismic shift, with patient engagement emerging as a critical factor in achieving better health outcomes and driving innovation. This change is further driven by major regulatory bodies emphasizing Patient-Focused Drug Development (PFDD).

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

As formulators, we are often able to directly impact the amount of drug absorbed through formulation optimization and improve exposure. However, the chances of improving the exposure profile of a drug that is highly cleared by formulation modification are limited.

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

The demand for injectable drugs is rising. According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. Several drug development trends are driving injectables demand.

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What’s next for Container Closure Integrity Testing?

Pharmaceutical Technology

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. Free Webinar. The evolution of CCIT. Wallis and Futuna.