Oversight of clinical investigators : action needed to improve timeliness and enhance scope of FDA's debarment and disqualification processes for medical product investigators : report to congressional requesters.

FDA oversight of clinical investigators.
Published: (2000)

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.
Published: (2009)

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.
Published: (2009)

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)

Drug safety : improvement needed in FDA's postmarket decision-making and oversight process : report to congressional requesters.
Published: (2006)

Drug Safety : Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process.
Published: (2006)

Drug Safety : FDA Has Begun Efforts To Enhance Postmarket Safety, but Additional Actions Are Needed.
Published: (2009)

Prescription drugs : improvements needed in FDA's oversight of direct-to consumer advertising : report to congressional requesters /
Published: (2006)

Prescription drugs : improvements needed in FDA's oversight of direct-to-consumer advertising : report to congressional requesters.
Published: (2006)

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

Medical devices : challenges for FDA in conducting manufacturer inspections : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives /
by: Crosse, Marcia
Published: (2008)

Guidance for industry and clinical investigators : the use of clinical holds following clinical investigator misconduct.
Published: (2004)

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

FDA's Faulty Safeguards Against Corruption : Concerns over Debarment Use and Authority.
Published: (2008)

FDA oversight--food inspection : hearings, Ninety-second Congress, first session ...
Published: (1972)

Medical devices : FDA review time : report to the chairman, Subcommittee on Oversight and Investigations, Committee on Commerce, House of Representatives.
Published: (1995)

FDA investigations operations manual /
Published: (1994)

Drug compounding : clear authority and more reliable data needed to strengthen FDA oversight : report to congressional requesters.
Published: (2013)

FDA human medical product user fee programs: in brief /
by: Bodie, Agata, et al.
Published: (2021)

The FDA medical device user fee program /
by: Johnson, Judith A. (Judith Ann), 1957-
Published: (2020)

Federal oversight of food safety : FDA has provided few details on the resources and strategies needed to implement its Food Protection Plan : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives /
by: Shames, Lisa
Published: (2008)

Food safety : improvements needed in FDA oversight of fresh produce : report to congressional requesters.
Published: (2008)

Food Safety : Improvements Needed in FDA Oversight of Fresh Produce.
Published: (2008)

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

Guidance for clinical investigators, institutional review boards, and sponsors : process for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations.
Published: (2006)

New Drug Approval : FDA Needs To Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints.
Published: (2009)

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)

Regulating innovation : FDA's medical device approval process : hearing before the Subcommittee on Investigations and Oversight of the Committee on Science, Space, and Technology, U.S. House of Representatives, One Hundred Third Congress, first session, September 17, 1993.
Published: (1994)

FDA's Technology Modernization Action Plan (TMAP).
Published: (2019)

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)

Vulnerabilities in FDA's oversight of state food facility inspections.
Published: (2011)

The challenge to improve patient safety : FDA logs over 350,000 reports of adverse events annually.
Published: (2002)

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

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

The FDA /
by: Lucas, Scott, 1937-
Published: (1978)

New drug approval : FDA's consideration of evidence from certain clinical trials : report to congressional requesters.
Published: (2010)