FDA Reopens Comment Period on Biological Products Development Workshop

The US Food and Drug Administration (Rockville, MD, www.fda.gov) has reopened the comment period for the notice of a public workshop dedicated to the development and availability of new biological products. Interested persons now have until 27 January 2006 to submit comments to the workshop entitled “From Concept to Consumer: Center for Biologics Evaluation and Research Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies,” which was held 7 October 2004.

The objective of the workshop was to provide an opportunity for attendees to discuss the development of innovative scientific knowledge and tools to facilitate the development and availability of new biological products, including vaccines, blood and blood products, and cellular, tissue, and gene therapies (Fed. Register 70 [17], 3935 [27 January 2005]).

The notice of public workshop and request for comments was originally published in the 31 August 2004 edition of the Federal Register. At that time, the agency provided only a 23-day period for submitting comments on the workshop’s topic. The January 2006 deadline now allows interested persons additional time for submitting comments and gathering information. Electronic comments specifying Docket Number 2004N-0366 can be submitted to http://www.fda.gov/dockets/ecomments.

–Maribel Rios