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Feb 26, 2015

New FDA Draft Guidance on Expanded Access:
Individual Patient Expanded Access Applications: Form FDA 3926

This guidance introduces and describes draft Form FDA 3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND)). When finalized, draft Form FDA 3926 will be available for licensed physicians to use for expanded access requests for individual patient INDs. Expanded access requests are sometimes referred to as compassionate use requests. Individual patient expanded access allows for the use of an investigational drug outside of a clinical investigation for an individual patient who has a serious or immediately life threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an investigational new drug application (IND) under § 312.23 for use in cases of individual patient expanded access. This draft guidance and draft Form FDA 3926 are not intended to apply to other types of expanded access requests, including requests for expanded access for medical devices.

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Does the TransCelerate RbM Guidance Offer Standardization?
Beat Widler & Peter Schiemann quoted on Applied Clinical Trials Blog Post

The concept of risk-based monitoring (RbM) is evolving, as nonprofit organizations continue to collaborate with the biopharmaceutical/medical device industry to investigate, pilot and implement RbM practices. While the industry seems to be getting closer towards implementing RbM programs, the subject is still at its infancy, as the industry explores this paradigm.

The biopharmaceutical/medical device industry is still trying to find ways to establish standardization in its business processes and technological infrastructures in order to seamlessly conduct RbM, however, current RbM practices lack standardization. This, in essence, defeats the core purpose of RbM, which involves generating reproducible and consistent results in monitoring and study execution quality.

Read the full blog post here

EMA updated their Q&A on GCP webpage
How should data be presented when they are sent to the inspection team prior to a GCP inspection requested by the CHMP?

In connection with centralized applications, the Committee for Medicinal Products for Human Use (CHMP) often requests a good clinical practice (GCP) inspection of one or more sites to be performed. Prior to such GCP inspections, the European Medicines Agency (EMA) sends an announcement letter to the applicant in which – among others – a list of documents to be provided to the inspection team is presented. The data are used by inspectors for review in order to select patients and data to inspect. Among the requested documents are the individual patient data listings for the patients recruited at the sites to be inspected. Based on past experience, this request for data listings poses a significant number of problems and subsequently costs a lot of time for companies and inspectors, quite often resulting in listings of suboptimal quality.

Read more online

FDA - CTTI recommendations for GCP training
How frequently is GCP training needed and what should be included?

A presentation on FDA - CTTI recommendations for GCP training (ICH E-6 GCP elements) and frequency (every 3 years) final recommendations to industry can be found accessible through the link below. Where this initiative leaves off for Principal Investigators and sites, other groups are addressing 'what this does not'...notably ACRES (Alliance for Clinical Research Excellence and Safety) and a NIH CTSA work stream (AHCs with CTSA-NIH grants) focusing on GCP education and training for the Clinical Research Professional.

(Courtesy of Liz Wool, QD-Quality & Training Solutions Inc.)

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