GMP News - Pharmaceutical Development / Clinical Trials / GCP

The FDA has published a draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials”. The purpose of this document is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products in the postmarketing setting in typically under-represented patient populations in clinical trials.

Critical inspection findings at a study center in India led the European Medicines Agency (EMA) to launch a referral process and to review potential implications for marketing authorizations in Europe. This followed a GCP inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which raised serious concerns about the validity and reliability of the study data generated by the CRO.

On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product  lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?

The USP revised the general chapter <1079.1> Storage and Transportation of Investigational Drug Products. With the revision reference is made to the new USP Chapter <1079.3> Monitoring Devices - Time, Temperature, and Humidity which will become official on 1 December 2023.

The Clinical Trials Coordination Group (CTCG) has published a Best Practice Guidance for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the CTD that need to be transitioned to the EU CTR.

The FDA issued a new guidance to provide general considerations to sponsors developing psychedelic drugs for medical use. According to the agency, there has been growing interest in the therapeutic potential of psychedelic drugs. This is the first FDA guidance that presents considerations for designing clinical trials for psychedelic drugs.