The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement. FDA issued an ...
The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better ...
Join RAPS Southern California, IPM, and Intertek for Connected Health at a Crossroads: Devices, Data, and Convergence, an evening of networking and thought-provoking discussion with MedTech leaders ...
The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) ...
The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing to ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top ...
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 ...
Recurring quality issues can feel like ghosts. You close a corrective and preventive action (CAPA), but then a few months later, the issue returns. While closing a CAPA proves the team completed a ...
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 ...
Boston Chapter In Person Event: 2026 Risks with Pharmaceutical & Medical Devices in the Supply Chain
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted ...
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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