Regulatory Blog

Yesterday (14-December-2022), USFDA published the revised final guidance “Failure to Respond to an ANDA Complete Response Letter Within...

Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new...

Earlier Today (07-December-2022), the U.S. Food and Drug Administration issued a final guidance, "Drug Products Labeled as Homeopathic...

Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...

Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...

Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for the API Master File...

Recently on 25th November, 2022 Philippines Food and Drug Administration (FDA) released two draft guidelines for comments i.e;...

Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...

Saudi Food & Drug Authority on 17th November 2022, released an updated guidance on "The Registration Rules of Pharmaceutical, Herbal and...

On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...

The Saudi Food and Drug Authority recently released (13- November-2022) updated guidance on "Conditional Approval for Medicinal Products...

Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...

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

Earlier today (November 8, 2022) USFDAs Center for Drug Evaluation and Research, Office of Generic Drugs released a Draft guideline on...

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

Earlier today (04-November-2022) the European Medicines Agency (EMA) released updated guidance on "Pre-Authorisation Procedural Advice...

Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...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