Regulatory Blog

The U.S. Food and Drug Administration (FDA) has finalized a pivotal guidance  addressing how the agency will decide when to begin and end...

On 25 September 2025 , the U.S. Food and Drug Administration (FDA) highlighted four critical updated or reaffirmed guidances  spanning...

On 22 September 2025 , the European Commission published new variations guidelines  in the Official Journal of the European Union. These...

On September 19, 2025, the U.S. Food and Drug Administration (FDA) released its revised draft guidance, “ Safety Labeling...

The U.S. Food and Drug Administration (FDA) released three important draft guidances  on September 11, 2025, providing updated...

The U.S. Food and Drug Administration (FDA) has released a new draft guidance " Development of Non-Opioid Analgesics for Chronic Pain "...

The U.S. Food and Drug Administration (FDA) has issued a final guidance on 11th September 2025 titled “ Alternative Tools: Assessing Drug...

Last week, two pivotal updates were introduced: the Union Health Ministry proposed major amendments to the New Drugs and Clinical Trials...

In 08 September 2025, the U.S. Food and Drug Administration (FDA) issued two final guidances addressing critical aspects of biosimilar...

On 1 September 2025 , Swissmedic published a set of updated guidance documents that refine requirements for medicinal product...

The Medicines and Healthcare products Regulatory Agency (MHRA) provides a detailed framework for conducting clinical investigations of...

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in regulating medicines, medical devices, and related...