After canceling a routine meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the composition of the 2025-2026 influenza vaccine, the US Food and Drug ...

To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website (s) for each country’s ministry of health and regulatory authority. The list is ...

Stakeholders say they want lower regulatory hurdles for cell and gene therapy (CGT) products, including streamlined pathways. Some researchers said updates to the US Food and Drug Administration@s ...

Bipartisan members of the Senate Appropriations Committee expressed concern about potential cuts to federal biomedical research funding and their support for stable funding at the National Institutes ...

ICH also touted its Q1 guideline on stability testing of drug substances, which was released for comment after reaching Step 2a/b in April just before the Madrid meeting, as well as its final E6 (R3) ...

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 ...

President Donald Trump@s order requiring the removal of 10 regulations, rules, or guidances for each new one issued will put administrative pressure the US Food and Drug Administration (FDA) and other ...

A week after firing hundreds of its probationary workers, the US Food and Drug Administration (FDA) has pulled an about-face and is asking some of those it laid off to return to their jobs.

Makary said some operational subject matter experts at FDA will be temporarily reassigned to the Office of Operations and will help the agency figure out how to make it more integrated and agile.

The US Food and Drug Administration (FDA) on Monday published a letter to Chinese medical device testing firm Mid-Link Technology Testing advising the company that all data from its studies will be ...

BASEL, SWITZERLAND – The International Council for Harmonisation (ICH) is developing a globally harmonized guideline on studying therapeutics in pregnant and breastfeeding individuals sometime this ...

Officials at the US Food and Drug Administration (FDA) are reportedly planning to reduce the number of routine inspections carried out by the Office of Inspections and Investigations (OII) after last ...