BIO Submits Comments on Financial Disclosure by Clinical Investigators Guidance

BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain relationships. It is important to recognize that relationships between industry and researchers have had an enormously beneficial impact on both research and patient care, and that policies addressing financial disclosure should not create disincentives for fruitful collaborations. We urge FDA to consider harmonization of the various reporting requirements as the Agency moves forward with this Draft Guidance. The majority of BIO members are small companies that do not yet have a product on the market. Ensuring that this Draft Guidance aligns with other reporting requirements will reduce inefficiencies and unnecessary regulatory burdens, thereby benefiting small companies with limited resources that seek to develop new products for patients.