Establishing Prevalence Or Incidence Of A Disease

The FDA recognizes any authoritative evidence to support the prevalence of 200 000 patients in the USA. The major sources of evidence include the following:

1. Peer-reviewed literature.

2. Textbooks.

3. Surveys by patient support groups.

4. Data from the National Disease and Therapeutic Index.

5. Hospital discharge data based on ICD codes or other clear classifications.

6. Data from the Centers for Disease Control.

7. Data from the National Center for Health Statistics.

8. Data from IMS or other reliable market data organizations.

9. Sales data of companies.

10. Testimony of a few experts, based on evidence from their (or other) hospitals or practices. This represents the weakest data.

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