The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing ...

This is an On-demand recording from May 2019. Sponsored by: The role of facilitator often falls to regulatory on development teams, a default decision which is both challenging and coherent. It is ...

The US Food and Drug Administration (FDA) recently posted four warning letters to pharmaceutical manufacturers in the US, Canada, and China for violations of current good manufacturing practices ...

The US Food and Drug Administration (FDA) has named Richard Pazdur to lead its drug center, just over a week after the departure of its former director, George Tidmarsh, who resigned amid an ...

ROTTERDAM, NETHERLANDS – A panel of experts raised concerns about the recently enacted EU Artificial Intelligence (AI) Act, which they said poses a significant burden on new medtech products and could ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Understand how labeling decisions fundamentally shape your promotional strategy. This event will tackle the common challenges of translating complex regulatory language into compelling yet compliant ...

During the second meeting of the US Food and Drug Administration@s (FDA) Digital Health Advisory Committee (DHAC), members of the panel seemed shocked and, at times, lost for words when grappling with ...

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) has released a new final guidance on preparing a pre-request for designation (Pre-RFD) with the Office of Combination Products (OCP), that contains ...

The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined plans for major reforms to streamline the process of testing, developing, and launching drugs for rare diseases in the UK. @ ...

WASHINGTON @ The US Food and Drug Administration (FDA) remains strong, despite recent turmoil in its leadership ranks, FDA Commissioner Marty Makary said at the Milken Institute@s 2025 Future of ...