The 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).
The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2002 and focuses on computer or software related information.
The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2003 and focuses on computer or software related information.
The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2004 and focuses on computer or software related information.
The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2005 and focuses on computer or software related information.
The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2006 and focuses on computer or software related information.
Example letter requesting FDA documents available due to Freedom of Information.
