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FDA Clarifies Expectations for Completeness Assessments for Drug Master Files

 
• By Joanne S. Eglovitch

FDA has clarified its requirements for DMF completeness acceptance following complaints that the draft guidance was too vague. FDA elaborates on what constitutes a single drug substance, single manufacturing process and starting materials.

FDA has clarified what it expects to see in drug master file (DMF) completeness assessments (CAs) for active pharmaceutical ingredients.

FDA’s expectations for CAs were outlined in final guidance issued in February 2016. The pharmaceutical industry had complained...

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More from United States

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• By Sarah Karlin-Smith

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Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
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• By Sue Sutter and Derrick Gingery

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Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

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More from North America

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.