martes, 6 de marzo de 2018

Complex Innovative Designs in Clinical Trials/ Pre-RFD Process/ BIMO Inspection Planning

1. Public Workshop: Promoting the Use of Complex Innovative Designs in Clinical Trials

FDA is conducting a public workshop to discuss the use of complex innovative designs (CID) in clinical trials of drugs and biological products. The purpose of this public meeting is to facilitate discussion and information sharing about the use of CID in drug development and regulatory decision making, and to obtain input from stakeholders about the CID pilot program.

The meeting will be held on Tuesday, March 20, 2018 from 8:30 a.m. – 5:00 p.m. at The FDA White Oak Campus in Silver Spring MD. If you are unable to attend the workshop in person, you can register to view a live webcast of the workshop. Registration for in-person attendance will close on March 13, 2018. 

FDA is seeking information and comments from a broad range of stakeholders. In addition to providing input at the public meeting, stakeholders are invited to submit comments through the public docket, which closes on April 20, 2018.

2. How to Prepare a Pre-Request for Designation (Pre-RFD)

This guidance is intended to assist sponsors in obtaining a preliminary assessment from the FDA through the Pre-Request for Designation (PreRFD) process. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP) and helps a sponsor understand the type of information to provide in a Pre-RFD. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product’s assignment to the appropriate Agency Center for premarket review and regulation.   

3. Submission of Content Necessary for Bioresearch Monitoring Inspection Planning for the Center of Drug Evaluation and Research 

The FDA has made available a draft guidance for industry entitled ‘‘Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions’’ along with the Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications (BIMO Technical Conformance Guide). These documents describe and provide specifications for the electronic submission of certain data and information in standardized formats. 

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