Regulatory Blog

Yesterday (18-November-2022) Tzield (teplizumab-mzwv) injection from ProventionBio has been approved by the U.S. Food and Drug...

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...

Recently (08-November-2022) the Medicines and Healthcare products Regulatory Agency (MHRA) released updated Guidance on the licensing of...

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

This week USFDAs Center for Biologics Evaluation and Research updated and released multiple guidances related to Gene therapy, Oncology,...

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Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...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

Recently in a new program announced by the Food and Drug Administration (USFDA), a limited number of applicants will be able to...

The Drug Regulatory Authority of Pakistan (DRAP) released a finalized guideline "Preparation of Summary of Product Characteristics...

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

Denmark's Danish Medicines Agency recently announced on 11th October 2022, going forward the current Danish QRD template is to be used...

Earlier on 21 October 2022, the USFDA released two finalized guidances "Multiple Endpoints in Clinical Trials" and "Human Gene Therapy...

The USFDA recently revised two compliance programs, which will go into effect from, October 17, 2022: Preapproval Inspections Drug...