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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA Issues FY2025 Report on the State of Pharmaceutical Quality
FDA is announcing the fiscal year 2025 Report on the State of Pharmaceutical Quality from the Office of Pharmaceutical Quality (OPQ). The mission of OPQ in FDA’s Center for Drug Evaluation and Research is to assure that quality medicines are available for the American public. In this report, OPQ analyzes FDA-registered drug manufacturers and their CDER-regulated drug products, including biologics, to inform stakeholders about the quality of the U.S. drug supply.
In addition to key data that characterize site quality and product quality, this report presents several deeper analyses:
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During CY2020-CY2025, the distributions of manufacturing locations for U.S.-based application products trended away from the U.S. and Europe and toward China and India.
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BLAs have increased from 2.3% of all approvals in FY2016 to 4.6% in FY2025 with biosimilars representing 42% of the approved BLAs in FY2025, up from 17% in FY2016.
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In FY2025, 74% of the pre-approval §704(a)(4) record requests were sent to foreign pharmaceutical firms, with the highest number sent to India and China.
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A study of benzene in OTC products found concentrations below 2 ppm and demonstrated that manufacturers can consistently meet lower limits.
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A study of diethylene glycol (DEG) and ethylene glycol (EG) in OTC drug products provided assurance to U.S. consumers about the quality of the tested products.
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A two-year review of original applications and supplements requiring facility assessments found that most facility withholds occurred at facilities with pre-existing Official Action Indicated (OAI)-related status.
We encourage the pharmaceutical industry and its stakeholders, including the public, to read this year’s report and collaborate with FDA to continuously improve the state of pharmaceutical quality.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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