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- FDA review highlights expanding role of manufacturing process models in drug applicationsThe FDA released a review outlining how manufacturers can incorporate process modeling into their regulatory submissions. Process models are described as a growing scientific area and are being us…
- MHRA revises guidance on periodic safety update reports for UK productsThe Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update to its pharmacovigilance procedures guidance. The revision focuses on the preparation and submission of periodic…