Regulatory Blog

On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...

Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the...

On July 25, 2024, the U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Center for...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research...

Yesterday (23 July, 2024) Swissmedic, the Swiss Agency for Therapeutic Products, has released updated guidance " Electronic exchange of...

On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...

Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...

The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...

The US Food and Drug Administration (USFDA) Center for Drug Evaluation and Research recently released updated guidelines "Pediatric...

Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...

The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16...

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth...

The Swissmedic released an updated guidance "Product information for Human Medicinal Products" which provides comprehensive instructions...

The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental...

The European Medicines Agency (EMA) provides detailed guidance "Procedural Advice on Paediatric Applications" that aims to facilitate the...

WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...

The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About...

Today (08 July, 2024) the US Food and Drug Administration (FDA) has released guidance "Purpose and Content of Use-Related Risk Analyses...