The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical ...
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 ...
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.
The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the Centrally License Approving Authority (CLAA) framework. Central and state ...
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.
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) 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 ...
The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices ...
India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological ...
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