Biologics FY 2006 - Images Long Description
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
- Somatic Cell & Gene Therapy
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.
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:
- Blood Vessels
- Bone and Cartilage
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