US FDA Disclaimer: The U.S. Food and Drug Administration procured the ChemDoodle software. The procurement does not explicitly state or imply that the US FDA endorses, recommends, or requires the use of this product or any other iChemLabs product.
An exact search for the structure of Penicillin V from ChemDoodle 2D in GSRS.
US FDA and iChemLabs Partnership
Richmond, VA, June 3, 2024 –
ChemDoodle is a leading chemical drawing and cheminformatics software designed to meet the rigorous demands of scientific research. The U.S. Food and Drug Administration (FDA) procured ChemDoodle for Agency-wide use. Our partnership allows FDA scientists and regulatory professionals to efficiently manage chemical structures, perform data analysis, and quickly collaborate with others.
Furthering our partnership, iChemLabs has provided the Agency with technical support and built additional regulatory tools. Two examples are direct access to the following FDA tools within the ChemDoodle application:
- Global Substance Registration System (GSRS) – facilitates seamless chemical substance registration
- Read and visualize Structure-Data Files (SDF), along with data records.
- Export chemical structures into an SDF and format according to the recommendations outlined in the Quick Guide to Creating a Structure-Data File (SD File) for Electronic Common Technical Document (eCTD) Submissions for ANDA, NDA, and BLA applications.
- Export chemical structures into an SDF and format according to the recommendations outlined in the Quick Guide to Creating a Structure-Data File (SD File) for DMF Submissions for Drug Master File (DMF) applications.
- Interface with GSRS and search for substance via substructure, exact, flex and similarity queries (any instance, including private GSRS hosts).
- precisionFDA – Query precisionFDA UNII Search Service from within ChemDoodle using a chemical structure.
The integration with GSRS and precisionFDA promotes an efficient review. Assessors can cross-reference data and verify chemical structures from Sponsors without having to switch between ChemDoodle and FDA platforms. This contributes to consistent data across the agency, aiding in decision-making processes and compliance requirements. These integrations are available for all ChemDoodle users, making it easier for professionals all around the world to query FDA’s public GSRS and precisionFDA instances.
"iChemLabs is proud to support the FDA in its mission to ensure public health and safety," said Kevin Theisen, President of iChemLabs. "Our integration with GSRS and precisionFDA demonstrates our commitment to providing robust and reliable tools for the scientific and regulatory communities."
A representative from the FDA noted, "Having a reliable and integrated chemical drawing software like ChemDoodle enables us to maintain consistency and accuracy across our processes, which is crucial for our work in protecting public health."
For additional information, please visit the ChemDoodle website or contact iChemLabs.
About US FDA:
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.
https://www.fda.gov/
About iChemLabs:
Since 2007, iChemLabs has been working to produce tools for chemists that are high quality, affordable and sustainable. We are experts in creating cheminformatics and chemical graphics software. Our products are used by thousands of institutions around the world and our work powers some of the most essential tools and companies in the industry.
https://www.ichemlabs.com/
Media Contact:
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