FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment: Information Gathering
The new article provides further clarifications related to gathering additional information.
The new article provides further clarifications related to gathering additional information.
The new article highlights the key aspects related to the way test articles should be extracted in order to ensure the accuracy and reliability of further assessment.
The new article explains in detail the way chemical analysis should be conducted in order to ensure any and all key matters are addressed properly.
The final article of the cycle provides additional clarifications regarding the matters related to data reporting.
The new article describes in detail the application process to be followed by the interested parties when applying for authorisations in the context of clinical trials.
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