For the purpose of this report, the subcommittee elected to construe the term "science" broadly, as encompassing all of the disciplines and activities within the FDA that have a scientific basis, e.g., research, review of submitted applications and petitions, development of scientific policy, guidelines and procedures, and the analytical and inspection responsibilities of the Office of Regulatory Affairs (ORA).
The term "scientific research" was taken to include both laboratory and non-laboratory investigation that addresses questions either of immediate applicability to present-day regulatory problems, questions that can be expected to arise in the near-term, and fundamental studies in areas of contemporary biomedical research that can reasonably be anticipated to affect FDA review and regulatory responsibilities over the longer-term, but foreseeable, future (an example of the last category might be research into candidate recombinant vaccines or biological response modifiers under development for commercial application). Under this definition, "scientific research" would exclude routine laboratory or non-laboratory testing and analysis using established methodologies, but would include the development of new analytical approaches and methodologies.
Hypertext created on 03/14/97 by Jonathan Boswell, OSB, Center for Devices and Radiological Health.