The International Council for Harmonization (ICH) has released a draft Q3E guideline that offers a harmonized framework for assessing and controlling extractables and leachables (E&L) in ...

The US Food and Drug Administration (FDA) kicked off the reauthorization process for the eighth iteration the Prescription Drug User Fee Act (PDUFA VIII) on Monday, with FDA Commissioner Marty Makary ...

Become a speaker or poster presenter in Lisbon The Euro Convergence Programme Committee invites you to propose a preconference workshop, concurrent session, solutions circle, or poster presentation ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid the groundwork for the implementation of new clinical trial regulations in April 2026 by publishing a series of guidelines.

WASHINGTON @ The US Food and Drug Administration (FDA) plans to make significant updates to its recently launched artificial intelligence (AI) tool Elsa within the next month and has taken critical ...

In an email to US Food and Drug Administration (FDA) staff on Wednesday, FDA Commissioner Martin Makary announced that Vinay Prasad, director of the Center for Biologics Evaluation and Research, will ...

WASHINGTON @ Marty Makary, commissioner of the US Food and Drug Administration (FDA), said he wants the agency to become nimbler in the next five years to adapt to the fast pace of medical innovation.

The International Council for Harmonisation (ICH) on Wednesday announced it will develop four new guidelines addressing real-world evidence, comparative efficacy studies, rare disease drug development ...

The US Food and Drug Administration (FDA) is exploring the possibility of changing the fee structure of the Prescription Drug User Fee Act program (PDUFA) to rebuild trust in the agency, said Grace ...

Australia@s Therapeutic Goods Administration (TGA) is running a consultation into plans to adopt three international scientific guidelines.

The US Food and Drug Administration (FDA) announced plans to implement AI tools throughout the agency to assist in conducting scientific reviews following the successful completion of a pilot program ...

The US Food and Drug Administration (FDA) has sent another warning letter to online retail giant Amazon for distributing unapproved new drugs. Additionally, three manufacturers of over-the-counter ...