GMP News Drug Safety/Pharmacovigilance

The European Commission (EC) published an updated Version of the Questions & Answers relating to the EU Clinical Trials Regulation (CTR). In particular, chapter 11 on transitional trials has been deleted and a new guidance document has been developed.

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.

EMA's GCP Inspectors Working Group added a new Question & Answer relating to Productivity Applications in the section "GCP matters" of the Good Clinical Practice (GCP) Q&As. What are the Expectations for Productivity Applications used in Clinical Trials?

In the context of the Drug Supply Chain Security Act (DSCSA), the U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act."

EMA's GCP Inspectors Working Group added a new Question & Answer in the section on "Records of Study Subject Data Related to Clinical Trials" of the GCP Q&As. What are the considerations when direct remote access of health data is required in a clinical trial?

The FDA has issued a new guidance together with a Guidance Snapshot which describes the agency's current thinking regarding adjusting for covariates in the statistical analysis of randomized clinical trials. According to the FDA, Sponsors should adjust for baseline covariates that are strongly associated with an outcome in a clinical trial population.