India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain. In 2022, the Indian government mandated that manufacturers of the top 300 ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter ...
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to ...
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance on submitting investigational device exemption ...
Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease ...
The US Food and Drug Administration (FDA) issued revised draft guidance on Thursday aimed at assisting sponsors of ...
Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), ...
The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and ...
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