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 ...

During a joint workshop on Monday, officials from the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) outlined efforts to reduce animal testing. FDA Commissioner Marty ...

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 International Council for Harmonisation (ICH) has released its highly anticipated draft guideline that harmonizes principles for the design, analysis, and reporting of adaptive clinical trials in ...

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.

The practice of a brand manufacturer delaying the launch of an authorized generic medication has declined over recent years, and its effects on the market can be both positive and negative depending ...

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 ...

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 US Food and Drug Administration@s (FDA) new artificial intelligence (AI) assistant, Elsa, has received mixed reviews from agency staff who spoke to Focus. While some staff say the tool has been ...

The Trump Administration is seeking $6.8 billion to fund the US Food and Drug Administration (FDA) in FY 2026 – an 11.5 percent cut from its current budget authority – with the agency looking to ...

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) on Tuesday announced a new framework for licensing COVID-19 vaccine boosters that would move away from the agency@s more universal approach to boosters to ...