Regulatory Blog

The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...

On 11 November 2022, the European medicines agency released updated guidance for sponsors about the "Procedural Advice for Orphan...

Today (04-November-2022) European Medicines Agency, released updated guidance on "Anonymisation of Protected Personal Data and assessment...

Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...

Earlier today (1-November-2022) the USFDA finalized and released "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based...

Recently the UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated their "150-day assessment for national applications...

Earlier today (27-October-2022) the Saudi Food & Drug Authority (SFDA) released updated guidance on "Good Regulatory Practice". A Good...

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a few guidances related to registration &...

USFDA's Oncology Center of Excellence released multiple guidances related to Oncology earlier today (17-Oct-2022). Guidance on:...

Center for Drug Evaluation and Research (CDER) finalized and released updated guidance on "ANDA Submissions – Prior Approval Supplements...

European Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has begun reforming medical device regulation to ensure software,...

Earlier today Today (13 October 2022) Medicines and Healthcare products Regulatory Agency (MHRA) updated its Guidance on Medicines:...

Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a couple of guidances related to Exporting active...

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued a Notification...

Philippines FDA (on 04-October-2022) released the draft “Revised Guidelines on the Unified Licensing Requirements and Procedures of the...

USFDA's Center for Devices and Radiological Health released two updated, finalized guidelines yesterday and earlier today...

Artificial Intelligence (AI) is a broad term that encompasses many different things and is a kind of intelligence that is created by a...