The Bio-IND is required by regulations in specific instances to ensure that proposed drug products that contain already approved, non-new chemical entities are safe for use in human test...
Bioanalytical Method Validation Guidance for Industry | FDA
2020年4月29日 · This final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most...
Validated analytical methods for the quantitative evaluation of analytes (i.e., drugs, including biologic products, and their metabolites) and biomarkers in a given biological...
FDA expands collaboration with CN Bio for PhysioMimix
2023年1月17日 · During the last five years of collaboration with CN Bio, the FDA has utilized the PhysioMimix Liver model for drug toxicity and metabolism studies resulting in the first co-publication, peer-reviewed article between an MPS provider and a regulator 2.
FDA Approvals & Clinical Development Pipeline - BIO
Join BIO as we champion for bringing new treatments to patients with serious medical conditions and to support policies that promote innovation and improve patient access.
BIO Statement on Resignation of Peter Marks from the FDA
6 天之前 · John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement regarding the resignation of Peter Marks from the FDA: “Under the extraordinary leadership of Dr. Peter Marks, the FDA shepherded in a new era of scientific breakthroughs -- from new vaccines to…
ImmunityBio, Serum Institute win FDA nod to combat BCG shortage
2025年2月19日 · With Merck & Co. largely propping up supplies of the bladder cancer-fighting bacteria Bacillus Calmette-Guérin (BCG) in the U.S., ImmunityBio has received the FDA all-clear to help pick up the...
Biosimilar Product Information | FDA
2025年3月3日 · The Food and Drug Administration approves biosimilar products and provides the scientific and regulatory advice needed to bring safe and effective biosimilars to market. The approval of...
BIO Statement on EPA/FDA/USDA Release of Plans for Reforming …
2024年5月8日 · “BIO is pleased to see today’s report released by EPA, FDA and USDA outlining the joint plan for regulatory reform under the Coordinated Framework for Regulation of Biotechnology to support and sustain biotech innovation …
BIO recommendations for FDA Rare Disease Innovation Hub
2024年11月8日 · The Biotechnology Innovation Organization (BIO) offered seven recommendations, informed by BIO’s continued collaboration with patient groups in the rare disease space.
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