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Pharmaceuticals / Regulatory Affairs

Gottlieb Updates House Appropriators on the FDA’s Status

March 7, 2019

FDA Commissioner Scott Gottlieb made his agency’s case before a key House appropriations subcommittee as the lawmakers begin the process of developing next year’s budget.

Gottlieb told the lawmakers that the agency is “undertaking one the most significant modernization efforts in decades” for its Office of New Drugs. The new effort includes “steps to update our approach to drug review across every stage in the life cycle of a new innovation, from the time an investigator first asks the FDA for permission to begin the clinical testing of a new drug to how we continue to assess the safety and effectiveness of new medicines after they're approved by the agency,” he said.

Beginning in the next few months, CDER will adopt new standard templates for its 30-day IND safety reviews and protocol reviews, Gottlieb added. This will better integrate the work of clinical and scientific reviewers and will improve the consistency of the IND reviews. It will also provide greater predictability to product developers, he said.

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