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Biologics FY 2006 - Images Long Description

<< Return to Biologics - Center for Biologics Evaluation and Research (CBER) - FY 2006 Budget Summary

  

Page 197

A chart entitled, "Biological Products Regulated by CBER", is in the top middle of the page. There are four concentric arrows forming a circle indicating a revolving movement.

The following products are listed:

  • Blood Derivatives
  • Whole Blood
  • Blood Components
  • Devices;Tissues
  • Xenotransplantation
  • Somatic Cell & Gene Therapy
  • AllergenicExtracts
  • Vaccines

 

  

 

Page 201 (top)

A picture chart entitled, "Research Support for Product Development," indicates the phases for product research to FDA filing stage.

The top arrow has five phases:

  • Basic Research;
  • Prototype design or discovery;
  • Preclinical development;
  • Clinical development;
  • FDA filing / approval & launch preparation

The middle arrow has a phase known as translational research.

The bottom arrow has a phase known as critical path research.

 

  

 

Page 201 (bottom)

The chart is entitled, "CBER Gene Therapy / Somatic Cell INDs Received - Compared to Other IND / IDE Receipts."

The X Axis is Fiscal Year 1998-2004

The Y Axis is total number of receipts ranging from 0 to 800. This total is comprised of the number of Other INDs and the number of Cell/Gene Therapy.

For 1998, there are 414 Other INDs and 124 Cell/Gene Therapy.

For 1999, there are 418 Other INDs and 169 Cell/Gene Therapy.

For 2000, there are 505 Other INDs and 146 Cell/Gene Therapy.

For 2001, there are 494 Other INDs and 117 Cell/Gene Therapy.

For 2002, there are 418 Other INDs and 110 Cell/Gene Therapy.

For 2003, there are 397 Other INDs and 109 Cell/Gene Therapy.

For 2004, there are 139 Other INDs and 104 Cell/Gene Therapy.

 

  

 

Page 202

The chart is entitled, "Human Tissues and Cells"

There is a diagram that shows the various human tissues and cells used in transplantation on the figure of a human body.

Clockwise, the body is labeled as follows:

  • Eyes
  • Blood Vessels
  • Skin
  • Tendons
  • Bone and Cartilage
  • Nerves

 

  

 

Page 210

There is a chart entitled "CBER Counterterrorism IND/IDE Receipts."

The X Axis is FY 2000 thru 2004

The Y Axis is the number of counterterrorism IND/IDE receipts

In FY 2000 there were 448 biological counterterrorism IND/IDE receipts.

In FY 2001 there were 483 biological counterterrorism IND/IDE receipts.

In FY 2002 there were 657 biological counterterrorism IND/IDE receipts.

In FY 2003 there were 992 biological counterterrorism IND/IDE receipts.

In FY 2004 there were 829 biological counterterrorism IND/IDE receipts

 

<< Return to Biologics - Center for Biologics Evaluation and Research (CBER) - FY 2006 Budget Summary