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 ...

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 ...

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 ...

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or ...

ROCKVILLE, MD @ Robert Lionberger, director of the US Food and Drug Administration@s (FDA) Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD), emphasized the critical need ...

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, ...

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.

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 ...

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 ...

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

Stakeholders are asking the US Food and Drug Administration (FDA) for further clarification on a draft guidance on optimizing doses for radiopharmaceutical therapies (RPT) to treat cancer. Some also ...