sábado, 8 de abril de 2017

New Workshops and Guidances: Antibody Mediated Rejection/ Engaging with CDER/ Pharmacogenomic Data Submissions/ Delayed Graft Function in Kidney Transplantation

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

New Workshops and Guidance Documents
1. Antibody Mediated Rejection (AMR) in Kidney Transplantation: an FDA - Public Workshop 
FDA is holding a public workshop regarding new developments and scientific issues related to antibody mediated rejection (AMR) in kidney transplantation. The workshop will be held on April 12-13, 2017 at the Tommy Douglas Conference Center - 10000 New Hampshire Ave., Silver Spring, MD 20903.  To register to attend this free event, visit the Antibody Mediated Rejection in Kidney Transplantation; Public Workshop webpage.
2. Roadmap for Engaging With the FDA/CDER - Public Workshop
FDA/CDER is announcing the following public workshop entitled “Roadmap for Engaging with FDA/CDER.” The public workshop will be held on May 12, 2017 at FDA’s White Oak campus in Silver Spring, MD.

To register to attend this event, either in person or via the web, visit the event registration page: FDA Public Workshop: Roadmap for Engaging with FDA's Center for Drug Evaluation and Research

3. Pharmacogenomic Data Submissions - Guidance for Industry 
This guidance document is intended to facilitate scientific progress in the field of pharmacogenomics and to facilitate the use of pharmacogenomic data in drug development. It provides recommendations to sponsors holding INDs, NDAs, and BLAs on (1) when to submit pharmacogenomic data to the Agency during the drug or biological drug product development and review processes, (2) what format and content to provide for submissions, and (3) how and when the data will be used in regulatory decision making.
4. Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention - Guidance for Industry
The purpose of this guidance document is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs for systemic drugs administered to the kidney transplant recipient to support an indication of prevention of DGF. This draft guidance is intended to serve as a focus for continued discussions among the Division of Transplant and Ophthalmology Products, pharmaceutical sponsors, the academic community, and the public. This guidance does not address the treatment of DGF in the recipient, or the treatment of the donor or the graft for the purpose of preserving or improving graft quality. These issues may be addressed in separate guidances.

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