Date Published:
Wed, 01/28/2009The FDA Globalization Act of 2009 has been submitted to Congress by Representative John Dingell (D-MI) to increase the FDA's scope of funding and authority.
See sections 201-212 for new provisions for pharmaceuticals and medical devices. It's worth noting that this bill proposes a risk-based approach to inspection frequency (Sec. 202) and use of Quality Risk Management Plans (Sec. 505).
Download:
Congressional Bill HR 759.pdf