Regulatory Blog

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...

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

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

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

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

This guidance was finalized and released by the Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and...

Earlier today (27 September 2022) MHRA released updated guidance on Good clinical practice for Clinical Trials where they had updated...

A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...

Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...

Swissmedic on Thursday released an updated guidance document on the eDok submission which as included new templates with minor other...

Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the...

Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...

Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...

On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...

On August 28, the Saudi Food and Drug Authority updated its "Guide to Good Manufacturing Practice for Medicinal Products". The new...

In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...

Multiple guidances were updated and released by the USFDA last week and had some important updates related to Drugs, Biologics, and...

On 22-July 2022, USFDA released multiple guidance among them one is "Failure to Respond to an ANDA Complete Response Letter Within the...

On 22-July 2022, USFDA released multiple guidance among them one is "Conducting Remote Regulatory Assessments Questions and Answers"....