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USA – FDA drafts guidance, orders on minor changes to OTC...
The Food and Drug Administration (FDA) has released draft guidance and a proposed administrative order regarding the documentation required for minor dosage form changes...
UK – MHRA releases spate of new guidelines on decentralized manufacturing
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for...
Europe – MDCG 2022-3 rev.1 – Verification of manufactured class D...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes
the requirements for notified bodies involved in the conformity assessment of applicable classes of...
Europe – 2024 annual report is published
EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions to public and animal health in the European Union...
