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) recently issued two warning letters to companies for marketing medical devices ...
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 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 Regulatory Reconnaissance, your regulatory news and intelligence briefing.
India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological ...
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 ...
The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the high ...
The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results