FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment: Chemical Analysis
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 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.
The new article explains the requirements pertaining to notifications for clinical trials, as well as the Good Clinical Practice requirements.
The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
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