Guidance for industry and FDA staff early development considerations for innovative combination products

Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff certifications to accompany drug, biological product and device applications/submissions : compliance with Section 402(j) of the Public Health Service Act, added by Title VIII of the Food and Drug Administration Amendments Act of 2007

Guidance for industry and FDA staff devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps)

Discussion drafts concerning Prescription Drug User Fee Act reauthorization, Medical Device User Fee and Modernization Act reauthorization, drug safety, and certain pediatric pharmaceutical and device legislation hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, June 12, 2007

A delicate balance : FDA and the reform of the medical device approval process : hearing before the Special Committee on Aging, United States Senate, One Hundred Twelfth Congress, first session, Washington, DC, April 13, 2011

Subcommittee hearing on the impact of competitive bidding on small businesses in the durable medical equipment community hearing before the Committee on Small Business, United States House of Representatives, One Hundred Eleventh Congress, first session, hearing held February 11, 2009

Medicare's DMEPOS Competitive Bidding Program hearing before the Subcommittee on Health of the Committee on Ways and Means, U.S. House of Representatives, One Hundred Tenth Congress, second session, May 6, 2008

Legislative hearing on H.R. 3593, H.R. 4261, H.R. 4281 and other draft legislation : hearing before the Subcommittee on Oversight and Investigation of the Committee on Veterans' Affairs, U.S. House of Representatives, One Hundred Thirteenth Congress, second session, Tuesday, March 25, 2014

Vendors in the OR : VA's failed oversight of surgical implants : hearing before the Subcommittee on Oversight and Investigations of the Committee on Veterans' Affairs, U.S. House of Representatives, One Hundred Thirteenth Congress, second session, Wednesday, January 15, 2014

Hearing on pending health care and benefits legislation : hearing before the Committee on Veterans' Affairs, United States Senate, One Hundred Fourteenth Congress, first session, June 24, 2015