Industry and other stakeholders want the US Food and Drug Administration (FDA) to provide more clarity and ensure flexibility in a revised guidance on how drug and medical device makers should communicate with payors and other stakeholders about their products.
A trade group has asked European authorities to give notified bodies access to the Eudamed database to empower them to deliver the risk-based oversight proposed in the pending medtech regulatory reforms.
The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities.
The European Medicines Agency (EMA) is running a consultation into plans to streamline the nonclinical development of treatments for severely debilitating or life-threatening diseases.
Two recent papers published in JAMA have highlighted the potential need for additional regulatory scrutiny for low-risk digital health technologies used by consumers.
A proposed amendment to 21 CFR Part 207 that eases registration rules for distributed manufacturers by allowing them to register as a single establishment could lead to a new paradigm where manufacturers shift their focus from product development to ensuring a product remains the same across multiple manufacturing sites.
Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council for Harmonisation (ICH), and the US Food and Drug Administration (FDA).
