Regulatory Blog

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

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

On 22 August 2025 , the U.S. Food and Drug Administration (FDA) released a comprehensive guidance document titled “ Animal Studies for...

On 18th August 2025, the U.S. Food and Drug Administration (FDA) recently published two important draft guidance documents that aim to...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 May 2025, the FDA, as part of the International Council for Harmonisation (ICH), endorsed and released for consultation the draft E21...

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...

Aluminum contamination in parenteral nutrition (PN) has long posed a silent but serious risk—especially to vulnerable populations like...

The stability of drug substances and drug products is a cornerstone of pharmaceutical quality, ensuring that medicines remain safe,...

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In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “ Transfer of a Premarket Notification...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