<Li> Food and Drug Administration (FDA)--PSWP may be disclosed to the FDA <Ul> <Li> By a provider concerning an FDA - regulated product or activity, </Li> <Li> By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA - regulated product or activity, or </Li> <Li> By a contractor acting on behalf of the FDA or entity for these purposes </Li> </Ul> </Li> <Ul> <Li> By a provider concerning an FDA - regulated product or activity, </Li> <Li> By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA - regulated product or activity, or </Li> <Li> By a contractor acting on behalf of the FDA or entity for these purposes </Li> </Ul> <Li> By a provider concerning an FDA - regulated product or activity, </Li> <Li> By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA - regulated product or activity, or </Li>

Patient safety & quality improvement act of 2005