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 ...

It can be challenging to ensure standard language is used when writing regulatory and medical documents, especially when every agency and customer has their own rules. This session explores how to ...

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 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 ...

Stakeholders are asking the US Food and Drug Administration (FDA) for further clarification on a draft guidance on optimizing doses for radiopharmaceutical therapies (RPT) to treat cancer.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

The US Food and Drug Administration (FDA) recently published three warning letters it sent to medical device manufacturers in China and Switzerland over quality system and current good manufacturing ...

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 ...

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

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 ...