Food and Drug Administration : FDA faces challenges meeting its growing medical product responsibilities and should develop complete estimates of its resource needs : report to congressional requesters.

Medical devices and the FDA : regulation, user fees and tort claims /
Published: (2013)

Use of investigational drugs and devices in humans and the use of Schedule I controlled drug substances : medical services.
Published: (1991)

Food and Drug Administration : data to measure the timeliness of reviews of medical device applications are limited : report to congressional committees.
Published: (2004)

Medical device reporting : improvements needed in FDA's system for monitoring problems with approved devices : report to congressional committees /
Published: (1997)

Medical devices : FDA faces challenges in conducting inspections of foreign manufacturing establishments : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives /
by: Crosse, Marcia
Published: (2008)

FDA's drug and device review process : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, second session, February 6, 1992.
Published: (1992)

Food and Drug Administration : Methodologies for Identifying and Allocating Costs of Reviewing Medical Device Applications Are Consistent with Federal Cost Accounting Standards, and Staffing Levels for Reviews Have Generally Increased in Recent Years.
Published: (2007)

Reinventing regulation of drugs and medical devices.
by: Clinton, Bill, 1946-
Published: (1995)

Health : drugs and medical devices : agreement between the United States of America and China, signed at Beijing, December 11, 2007.
Published: (2013)

Food and Drug Administration Reform Act of 2012 : report (to accompany H.R. 5651) (including cost estimate of the Congressional Budget Office).
Published: (2012)

Food and Drug Administration : employee performance standards for the timely review of medical product applications /
by: Crosse, Marcia
Published: (2012)

Mastering and managing the FDA maze : medical device overview : a training and management desk reference for manufacturers regulated by the Food and Drug Administration /
by: Harnack, Gordon, 1939-
Published: (1999)

Discussion draft of the Food and Drug Administration Globalization Act legislation : device and cosmetic safety provisions : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, May 14, 2008.
Published: (2008)

Filthy food, dubious drugs, and defective devices : the legacy of FDA's antiquated statute : a staff report /
Published: (1991)

Food and Drug Administration : Approval and Oversight of the Drug Mifeprex.
Published: (2008)

Reinventing the regulation of cancer drugs : accelerating approval and expanding access.
by: Clinton, Bill, 1946-
Published: (1996)

Safety testing of new drugs : laboratory predictions and clinical performance /
Published: (1984)

Medical device regulation : too early to assess European system's value as model for FDA : report to the Chairman, Committee on Labor and Human Resources, U.S. Senate /
Published: (1996)

Medical devices : hearing before the Committee on Labor and Human Resources, United States Senate, One Hundred First Congress, second session, on examining proposed legislation to revise and strengthen the Food and Drug Administration's regulation of medical devices, July 25, 1990.
Published: (1991)

Mejor cuidado de la salud con dispositivos médicos de calidad : FDA a la cabeza en tecnología de dispositivos médicos.
Published: (2002)

The law and regulation of medicines and medical devices /
by: Feldschreiber, Peter
Published: (2021)

Anesthesia machine failures : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, Ninety-eighth Congress, second session, September 26, 1984.
Published: (1985)

The impact of medical device and drug regulation on innovation, jobs, and patients : a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011.
Published: (2012)

Reviewing FDA's implementation of FDASIA : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, November 15, 2013.
Published: (2014)

Guidance for industry : presenting risk information in prescription drug and medical device promotion.
Published: (2009)

Medical devices: FDA has begun building an active postmarket surveillance system : report to congressional requesters.
Published: (2024)

FDA user fees : advancing public health : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... July 28, 2011.
Published: (2014)

Reprocessed Single-Use Medical Devices : FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Risk.
Published: (2008)

Food and Drug Administration : revenue information on certain companies participating in the Medical Device User Fee Program.
by: Williamson, Randall B.
Published: (2007)

Medical devices : FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process : report to congressional addressees.
Published: (2009)

The Bjork-Shiley heart valve : "earn as you learn" : Shiley Inc.'s breach of the honor system and FDA's failure in medical device regulation : a staff report prepared for the use of the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, U.S. House of Representatives.
Published: (1990)

FDA user fees and the regulation of drugs, biologics, and devices : comparative analysis of S. 3187 and H.R. 5651 /
by: Thaul, Susan
Published: (2018)

FDA oversight : medical devices : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, Ninety-seventh Congress, second session, July 16, 1982.
Published: (1982)

Performance report to Congress for the Medical Device User Fee and Modernization Act of 2002.
Published: (2003)

Medical devices : protecting patients and promoting innovation : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... November 15, 2011.
Published: (2014)

Guidance for industry, FDA staff, and FDA-accredited third parties.
Published: (2009)