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AdComms – Is FDA Getting Less Advice?

Eye on FDA

As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. There are 31 advisory committees on matters ranging from food to medical devices to pediatric care.

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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law Blog: Drug Discovery

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

Improving efficacy with ADCs The widely quoted notion that ADCs increase the therapeutic window by lowering the minimum effective dose (MED) and increasing the maximum tolerated dose (MTD) is not supported by clinical data from human studies, indicating the MTD of ADCs is not significantly different from small molecules.

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News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”

Cytel

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus.

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Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

While traditionally conducted during Phase 2 or later, the FDA has recently been requesting data sooner in the development process, making it critical to implement proactive AME studies to lay the groundwork for advanced phases of your clinical program. To accomplish this, we pay careful attention to both dosing and sample collection.

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Strategies for Recovering from an Unsatisfactory Pre-IND Meeting

The Premier Consulting Blog

Premier Consulting’s regulatory strategists specializing in the US FDA’s 505(b)(2) approval pathway are often asked how a sponsor can recover from a pre-IND meeting that doesn’t go as planned. Start by analyzing the feedback received during the meeting and thoroughly reviewing the FDA’s recommendations and suggestions.