Newsletter | July 30, 2024

07.30.24 -- FDA Finalizes Guidance About Delaying Or Refusing An Inspection

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FEATURED EDITORIAL

FDA Finalizes Guidance About Delaying, Limiting, Or Refusing An Inspection

The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

INDUSTRY INSIGHTS

Optimizing Cell Therapy Supply Chains For Success

When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.

The Present And Future Of Study Supply Management

Gain expert insights on the future of RTSM strategy and its evolution with the changing clinical supply and technology landscape in our webinar.

Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio

Learn how the CRO ClinChoice and the sponsor 89Bio addressed their need to pivot to a decentralized protocol during the pandemic or face trial disruption.

SOLUTIONS

Medrio RTSM

De-Risking Your Bioconjugate's Path To Clinical Manufacturing