Regulatory Blog

On 18th August 2025, the U.S. Food and Drug Administration (FDA) recently published two important draft guidance documents that aim to...

Artificial Intelligence and Machine Learning (AI/ML) are increasingly used in medical devices—from diagnostic imaging software to digital...

The U.S. Food and Drug Administration (FDA) has announced On 30 July 2025 , the official user fee rates across its major healthcare...

On 30 July 2025, the U.S. Food and Drug Administration (FDA) officially published the Biosimilar User Fee Rates for Fiscal Year (FY) 2026...

In July 2025, the USFDA published a revised guidance titled " Medical Device User Fee Small Business Qualification and Determination "...

In July 2025, the U.S. Food and Drug Administration (FDA) published its updated guidance for industry titled “ Formal Meetings Between...

Myelodysplastic syndromes (MDS) are a group of complex, clonal blood disorders that predominantly affect older adults and may progress to...

In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency  are more crucial than ever. The FDA’s...

The U.S. Food and Drug Administration (FDA) has released an updated guidance " ANDAs: Pre-Submission Facility Correspondence Related to...

In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “ Transfer of a Premarket Notification...

In a major step toward global harmonisation of clinical trial processes, the U.S. Food and Drug Administration (FDA) and the...

What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...

Developing drug products across multiple strengths is a common strategy in pharmaceutical formulation, allowing dose flexibility and...

As medical technology advances, the FDA’s regulatory frameworks continue evolving to ensure timely, safe, and effective device...

A color additive is any dye, pigment, or substance that imparts color to a drug. Only color additives listed in FDA regulations are...

The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...

In March 2025, the U.S. Food and Drug Administration (FDA) released a final guidance titled “ Evaluation of Sex-Specific Data in Medical...

The U.S. Food and Drug Administration (FDA) has announced the release of " Over-the-Counter Monograph Drug User Fee Program-Facility Fee...

The Medicines and Healthcare Products Regulatory Agency (MHRA) published its comprehensive guidance titled “ Applying Human Factors and...

The U.S. Food and Drug Administration (FDA) released final guidance " Premarket Approval Application and Humanitarian Device Exemption...