Drugs

ICH Drug Submission Quality Information Guidance

FDA has published for review and comment an International Council for Harmonization guidance, The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality, M4Q(R2), establishing the location and structure of quality information for registration applications of all medicinal products for human use. The document says it supports various submission types, including those for master files, and applies to both initial marketing authorization and post-approval submissions. It says it is structured to be flexible to accommodate all types of medicinal products and their components.

“The M4Q(R2) structure is presented in a globally harmonized format with sufficient granularity to facilitate digitalization and organized for easy access, analysis, and knowledge management,” it says. “This granularity also supports inclusion of information from emerging concepts, such as advanced manufacturing, use of structured data management processes, artificial intelligence/machine learning, bioinformatics, and advanced analytical tools. The applicant should include applicable information on these tools within the relevant sections of the dossier pertinent to their specific application. Novel processes or technologies that directly impact product quality may be described in greater detail to ensure clarity and comprehension.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome