Annual Report Forms for Postmarketing Requirements
The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.
The U.S. Food and Drug Administration (FDA) issued the final document, "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors". Amongst others, the guidance clarifies who is responsible for the specific areas related to informed consent that should be considered.
How to Obtain Data on Populations Underrepresented in Clinical Trials
The FDA has published a draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials”.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.
GCP Inspection Reveals Deficiencies at CRO in India
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.
Ethylene and Diethylene Glycol Testing again in Focus of FDA Warning Letters
In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.
WHO issues draft Guidance on Best Practices for Clinical Trials
The World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The document is intended to provide guidance to WHO’s Member States and any staff members of non-State actor organizations whose work is related to clinical trials.
New EMA Reflection Paper on the use of Artificial Intelligence
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?
US Verification Requirements: 1 Year Additional Time for Wholesale Distributors & Dispensers
To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.
Clinical Trials Regulation - Version 6.5 of the Q&As
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.
Best Practice Guide for Transitional Clinical Trials
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.
FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
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.
Can Productivity Applications be Used in Clinical Trials?
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?