While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more first ...
The top generic drug regulator at the US Food and Drug Administration (FDA) on Wednesday touted the drop in refuse-to-receive (RTR) decisions his office issued for abbreviated new drug applications ...
The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices ...
The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical ...
The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing ...
The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
CDER plans new guidance on AI, electronic safety report submissions, and more FDA headquarters in White Oak, Md. (Credit: Ferdous Al-Faruque) The US Food and Drug Administration’s (FDA) Center for ...
India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological ...
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, ...
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 ...
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