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USP action plan for generics and FDA new innovation office Posted 01/03/2019

The US Pharmacopeia (USP) has issued an action plan to promote generics and the US Food and Drug Administration (FDA) has announced the creation of a new office for drug innovation.

In February 2019, as part of its efforts to increase patient access to medicines by increasing generics competition, the USP released a Generics Access Plan. The plan offers new and revised quality standards, training and education, and collaborates with FDA.

The USP is the only independent, not-for-profit, non-governmental pharmacopeia in the world. The USP sets quality, purity, strength and identity standards for medicines, food ingredients and dietary supplements. Its Generics Access Plan includes:
• Support of FDA’s Drug Competition Action Plan (DCAP) priorities, including FDA’s list of off-patent drugs for which generic alternatives are not available on the market
• Offering training and education for generics manufacturers worldwide on best practices for applying quality standards to enhance the capabilities for producing quality generics
• Convening regulators, industry representatives, patient groups, payers, healthcare practitioners and others to identify additional ways to support generics development through the standard-setting process and educational programming

In January 2019, FDA Commissioner Scott Gottlieb announced the creation of a new office to help streamline the agency’s review of new drugs. The Office of Drug Development Science (ODES) will operate within the Center for Drug Evaluation and Research (CDER)’s Office of New Drugs and work to standardize the review process.

FDA Commissioner Scott Gottlieb said that drug innovation is costly because ‘the science of prediction is costly and uncertain’. This new office aims to advance innovation in drug development by leveraging improved understanding of biomarkers and other advances to build tools that take some of the risks and costs out of drug development. The office will focus on clinical outcome assessments, biomedical informatics and safety analytics and biomarker development.

The office also aims to make applications cloud based. Therefore, instead of taking the sponsors’ charts and tables and evaluating their charts and tables, sponsor data will be used and formatted through FDA’s own assessment tools and the office will create its own charts and tables to do the evaluation.

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Source: USP, US FDA

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