Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the ...
Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...
India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain.
Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance ...
Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) ...
Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of ...
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, ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focu ...
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