This article provides a comprehensive overview of recent changes in US trade policy. It highlights key developments such as new global tariffs and bilateral trade agreements, sector- and ...

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

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 ...

This event focuses on two key areas in MedTech: the distinction between wellness and regulated health technologies, and the integration of artificial intelligence throughout the product lifecycle.

The US Food and Drug Administration (FDA) announced a streamlined approach to developing biosimilars that could eliminate the need for drugmakers to conduct comparative efficacy studies (CES) 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, FDA ...

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

The US Food and Drug Administration@s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) recently released net hiring data that shows steep ...

The US Food and Drug Administration (FDA) on Tuesday reprimanded a US manufacturer and contract testing lab, BRS Analytical Services, for producing eye drops under unsanitary conditions, and an ...

SAN DIEGO @ While medical device makers are required to provide a software bill of materials (SBOMs) for their products, experts who spoke at the 2025 Medtech Conference said that the available tools ...

PITTSBURGH @ The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, ...

Australia@s Therapeutic Goods Administration (TGA) is seeking feedback on plans to temporarily exempt bacteriophage therapy products from good manufacturing practice (GMP) requirements.