Drug Development Consultant & Regulatory Consultant » clinical

FDA publish guidance on the use of histology in biomarker qualification studies

damienbove — Sat, 04 Feb 2012 13:22:04 +0000

This guidance is for sponsors who wish to conduct biomarker qualification studies which use histology as a reference standard. It gives people guidance on processes that should be considered to ensure quality and integrity of the data in the biomarker studies and outlines the scientific standards should be used in biomarker characterisation and qualification. It is intended to provide recommendations support the proposed context of use where scientifically rigourous evaluation is essential. This applies to exploratory biomarker studies, but not to nonclinical safety assessment studies.

FDA Publish Guidance on IDEs and INDs for Repair or Replace Knee Cartilage

damienbove — Thu, 02 Feb 2012 13:17:00 +0000

This guidance document provides answers of investigational device exemption application (IDE) on investigational new drug application (IND) recommendations about the information they need to include within their submission on describing their products but is intended to replace or repair knee cartilage.

This guidance supplements other recommendations in the area of drugs and biologicals and devices provide recommendations specific to cartilage repair or replacement. the FDA considers these products a significant risk area, and requires you to have specific approval from the FDA conducting research in this area. Advice from the institutional review board is no longer sufficient.

FDA publishes guidance on the general principles for the development of vaccines for global infectious diseases

damienbove — Fri, 30 Dec 2011 09:49:17 +0000

The FDA is provided guidance to assist sponsors in developing vaccine to protect against global infectious diseases. The guidance focuses on development of licence of vaccines for infectious diseases or conditions endemic in areas outside the United States. It aims to clarify regulatory status and guidance already published for development of these products.

Full guidance given below

EMA publish concept paper on updates to guidance on clinical development in HIV

damienbove — Mon, 19 Dec 2011 09:56:34 +0000

There are over 20 antiretroviral agents (ARTs) belonging to several classes that have been approved in the European Union. Recent approvals have seen improved tolerability and more convenient dosing regimens thus the therapeutic goal of most patients has changed in recent years as most are now aiming to suppress plasma viral load. However there are still a few patients that do not achieve sustained viral suppression either due to viral resistance or an inability to tolerate certain agents combinations. This changing landscape has pushed the MA towards changing guidance was adopted in 2008. New agents greatly enhance the likelihood that treatment experienced patients can achieve sustained viral suppression and thus the pool of failed patients has been constant dribbling reduced. However new anti-viral therapies are still needed. Existing guidance does not provide a feasible regulatory path the clinical development of such agents.

This concept paper looks at tackling this now complex drug development environment for HIV antiretroviral therapies.

NICE publishes guidance on colorectal cancer diagnosis and management

damienbove — Sat, 17 Dec 2011 08:54:50 +0000

This comprehensive clinical guidance published by nice on colorectal cancer covers the diagnostic investigations that are required, the methodologies that are approved for the staging of colorectal cancer, preoperative management of the primary tumour, colonic stents that can be used in acute large bowel obstruction, treating stage one colorectal cancer, imaging hepatic metastases, outlines approved chemotherapy for advanced and metastatic colorectal cancer, provides follow-up for apparently curative resection and gives background information about bowel function related to the treatment of colorectal cancer.

FDA published guidance on clinical considerations for therapeutic cancer vaccines

damienbove — Fri, 16 Dec 2011 08:43:46 +0000

The guidance covers critical clinical considerations for investigational studies in phase 1 and two clinical trials and phase 3 clinical trials. The guidance makes recommendations for the design of clinical trials conducted under an IND to spot subsequent biological license applications. This is finalisation draft guidance was published in September 2009.

the product discussed in this guidance are therapeutic cancer vaccines intended to result in specific responses to tumour antigens and are intended to treat patients with an existing cancer. These products are traditionally regulated by the Centre for Biological Evaluation Research (CBER) and are referred to as cancer vaccines throughout this document.

FDA publishes draft guidance on ICH E2B(R3) electronic transmission of individual case safety reports implementation guide

damienbove — Thu, 08 Dec 2011 16:24:29 +0000

The FDA has published this draft guidance in response to international conference on harmonisation of technical requirements for the register duration of pharmaceuticals for human use meetings and publications. This guidance is specific to the requirements of data elements and message specification.

the ICH E2B(R3) message standard is built upon health level III ICSR release free standard. Conceptually this report of information describing adverse events or reactions experienced by an individual patient; the events and reactions can be related to the administration of one or more medicinal products at a particular point in time. The ICSR can also be used exchange other information such as medication errors that do not involve adverse events or reactions.

The FDA sees the guidance as supporting the implementation of software tools for creating, editing, sending and receiving electronic IC SR messages. If you do not see it as a guide pharmacologist practices nor is it intended to explain the underlying scientific or medical issues that support the correlation categorisation or analysis of safety information.

EMA published a concept paper on updating guidance for medical products to treat bacterial infections

damienbove — Wed, 07 Dec 2011 16:20:59 +0000

The EMA has published a concept paper inviting input from industry into a proposed update to the guidance on the evaluation medicinal products indicated for treat bacterial infections, to address indication specific clinical data requirements.

this initiative follows several requests were made to the CH MP to provide more detailed guidance on issues such as Pearson selection criteria and primary endpoints including efficacy variables and the timing of assessment outcomes. Specific interest was laid out non-inferiority study designs that would be acceptable to the regulators. A number of enquiries were concerned about the feasibility of achieving superiority endpoints in clinical studies and more guidance was needed to assist companies developing clinical programs that would be feasible and meet with regulatory approval in this area.

In response to this the EMA held a number of workshops and are now looking to make changes to the guidance to meet these issues.

FDA publishes guidance for industry on warnings and precautions and contraindications.

damienbove — Tue, 29 Nov 2011 10:58:55 +0000

The FDA publishes guidance that is intended to assist applicants and reviewers in drafting the warnings and precautions, contraindications, and boxed warning sections of labelling, as described in the final rule amending the requirement for the content and format of labelling for human prescription drugs and biological products. Continue reading →

FDA published appendix to electronic transmission of individual case report safety implementation guide

damienbove — Mon, 28 Nov 2011 10:55:25 +0000

The FDA as published in appendix to its guidance on the electronic transmission of individual case safety reports (ICRS) which is an implementation guide for international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use and to electronic message of the transmission of individual case safety reports.

The appendix is intended to assist reports and recipients in implementing the systems with a special focus on the recommendations come version back and forth between previous standards.

excerpt from document

full text here

This document is an appendix to the guide for implementing the “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2: Electronic Message for the Transmission of Individual Case Safety Reports (ICSRs).”
This Appendix is intended to assist reporters and recipients (including pharmaceutical companies, authorities and non-commercial sponsors) in implementing systems with special focus on the recommendations for conversion back and forth between the previous standard, i.e., E2B(R2) and this new one, i.e., E2B(R3).
The evolution of the guideline, from E2B(R2) to E2B(R3), has the consequence that ICSRs cannot be perfectly converted from one standard version to the other (either backwards or forwards). This document presents the recommendations for conversion agreed within ICH so as to provide a reference to system providers, and a common understanding on the way to convert ICSRs and ICSR acknowledgments (ICSR ACKs) between E2B(R2) and E2B(R3).