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# Human Drugs - Center For Drug Evaluation and Research (CDER) FY 2006 - Images Long Description

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The chart is entitled, "*Tentative Approvals and Approvals [for Generic Drugs]*"

The X Axis is Fiscal Year 1998-2004

The Y Axis is Number of Approvals including tentative approvals ranging from 0 to 450.

For 1998, there are 230 tentative approvals and 19 approvals.

For 1999, there are 198 tentative approvals and 68 approvals.

For 2000, there are 232 tentative approvals and 62 approvals.

For 2001, there are 241 tentative approvals and 69 approvals.

For 2002, there are 296 tentative approvals and 68 approvals.

For 2003, there are 284 tentative approvals and 89 approvals.

For 2004, there are 320 tentaive approvals and 93 approvals.

The chart is entitled, "*Sources of Risk from Medical Products*."

The left text box is entitled "Known Side Effects," with two sub-components (Unavoidable and Avoidable).

A downward arrow flows from the Unavoidable side effect to a box called Injury or Death. The downward arrow flows from the avoidable side effect into a box called preventable adverse event.

The top middle box is entitled, "Medication and Device Error." A downward arrow points to a text box entitled, "Preventable Adverse Events." From that box, a downward arrow points to a box entitled, "Injury or Death."

The right box is entitled, "Product Defects," and an arrow points to the box entitled, "Preventable Adverse Events."

To the right of the "Injury or Death" box, there is box entitled, "Remaining Uncertainties." There three uncertainties are:

- Unexpected side effects;
- Unstudied uses; or
- Unstudied populations.

The graph is entitled "*CDER Post-Marketing Adverse Event Reporting: Electronic Submissions*."

The X access is FY 2000-2004

The Y axis is the number of ISRs ranging from 0 to 100,000.

There are two types of reports being measured on the Y axis: 15 day expedited electronic submissions and periodic submissions

In FY 2000 there were 537 15 day expedited electronic submissions and 0 periodic submissions

In FY 2001 there were 12,240 15 day expedited electronic submissions and 1,805 periodic submissions.

In FY 2002 there were 20,900 15 day expedited electronic submissions and 0 periodic submissions.

In FY 2003 there were 26,053 15 day expedited electronic submissions and 9,955 periodic submissions.

In FY 2004 there were [ ] 15 day expedited electronic submissions and [ ] periodic submissions.

The chart is entitled, "*Approval Times - Media*n" for generic drugs.

It shows the median time in months for Fiscal Years 1995 through 2004.

The amount of time ranges from 0 to 30 months.

In 1995, the median time was 28.2 months.

In 1996, the median time was 24.7 months.

In 1997, the median time was 19.6 months.

In 1998, the median time was 18.7 months.

In 1999, the median time was 17.3 months.

In 2000, the median time was 18.9 months.

In 2001, the median time was 18.4 months.

In 2002, the median time was 18.3months.

In 2003, the median time was 17.3 months.

In 2004, the median time was 16.3 months.

The graph is entitled "*Receipts of Original ANDAs*."

The Y Axis is Number of Original ANDA Submissions ranging from 0 to 600 submissions.

The X Axis is Fiscal Year 1998 through 2004

The total receipt of Original ANDAs in 1998 is 346

The total receipt of Original ANDAs in 1999 is 326

The total receipt of Original ANDAs in 2000 is 335

The total receipt of Original ANDAs in 2001 is 307

The total receipt of Original ANDAs in 2002 is 361

The total receipt of Original ANDAs in 2003 is 449.

The total receipt of Original ANDAs in 2003 is 563.

This is graphic chart entitled, "*Why is it important to know that all of these medicines contain acetaminophen?*"

This chart is downsized and is used as an example of CDER's public advisory mission.

Underneath the sentence is a picture of medicine spoon, tablet sheets, different size pills, and liquid dosage dispenser.

Another statement is made. It states "Because too much can damage your liver." A further explanation is provided but it is too small to read. PLEASE NOTE: The chart is used an example of CDER's outreach efforts. -

At the bottom of the chart is the Department's and FDA's indicia (symbol) and mailing address.

The graph is entitled "*CDER Post-Marketing Adverse Event Reporting: Electronic Submissions.*"

The X access is FY 2000-2004

The Y axis is the number of ISRs ranging from 0 to 100,000.

There are two types of reports being measured on the Y axis: 15 day expedited electronic submissions and periodic submissions

In FY 2000 there were 537 15 day expedited electronic submissions and 0 periodic submissions

In FY 2001 there were 12,240 15 day expedited electronic submissions and 1,805 periodic submissions.

In FY 2002 there were 20,900 15 day expedited electronic submissions and 0 periodic submissions.

In FY 2003 there were 26,053 15 day expedited electronic submissions and 9,955 periodic submissions.

In FY 2004 there were [ ] 15 day expedited electronic submissions and [ ] periodic submissions.

<< Return to Human Drugs - Center For Drug Evaluation and Research (CDER) - FY 2006 Budget