Patients who reviewed and signed a patient agreement form (PAF) for mifepristone and misoprostol under the US Food and Drug ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In a final guidance issued on Monday, the US Food and Drug Administration (FDA) laid out its expectations for cell and gene ...
Australia’s Therapeutic Goods Administration (TGA) is holding consultations on information sharing under clinical trial ...
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 ...
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The US Food and Drug Administration (FDA) on Tuesday issued draft guidance on submitting investigational device exemption ...
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...
The US Food and Drug Administration (FDA) issued revised draft guidance on Thursday aimed at assisting sponsors of ...
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