United States, Food and Drug Administration -- Rules and practice
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United States, Food and Drug Administration -- Rules and practice
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The concept United States, Food and Drug Administration -- Rules and practice represents the subject, aboutness, idea or notion of resources found in University of Missouri Libraries.
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- 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
- Allegations of FDA abuses of authority : hearing before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Fourth Congress, first session, July 25, November 15, and December 5, 1995
- An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise and Extend the User-Fee Programs for Prescription Drugs and for Medical Devices, to Enhance the Postmarket Authorities of the Food and Drug Administration with Respect to the Safety of Drugs, and for Other Purposes
- Antibiotics : FDA needs to do more to ensure that drug labels contain up-to-date information : report to congressional committees
- Blood supply : FDA oversight and remaining issues of safety : report to the ranking minority member, Committee on Commerce, House of Representatives
- Blood supply : transfusion-associated risks : report to the ranking minority member, Committee on Commerce, House of Representatives
- Bottled water : FDA safety and consumer protections are often less stringent than comparable EPA protections for tap water : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives
- Committee staff report to the chairman and ranking member : review of the FDA's approval process for the vagus nerve stimulation therapy system for treatment-resistant depression
- Department of Health and Human Services, Food and Drug Administration : applications for FDA approval to market a new drug : patent submission and listing requirements and application of a 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed
- Department of Health and Human Services, Food and Drug Administration : food labeling : trans fatty acids in nutrition labeling, nutrient content claims, and health claims
- Dietary supplements : FDA should take further actions to improve oversight and consumer understanding : report to congressional requesters
- Drug safety : FDA faces challenges overseeing the foreign drug manufacturing supply chain : testimony before the Committee on Health, Education, Labor, and Pensions, U.S. Senate
- Drug safety : FDA has begun efforts to enhance postmarket safety, but additional actions are needed : report to the Ranking Member, Committee on Finance, U.S. Senate
- Drug safety : FDA has conducted more foreign inspections and begun to improve its information on foreign establishments, but more progress is needed : report to the Committee on Oversight and Government Reform, House of Representatives
- Drug safety : FDA needs to further address shortcomings in its postmarket decision-making process : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives
- Drug safety : better data management and more inspections are needed to strengthen FDA's foreign drug inspection program : report to congressional requesters
- Drug safety : further actions needed to improve FDA's postmarket decision-making process : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives
- Drug safety : improvement needed in FDA's postmarket decision-making and oversight process : report to congressional requesters
- Drug safety : preliminary findings suggest recent FDA initiatives have potential, but do not fully address weaknesses in its foreign drug inspection program : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives
- Drug safety : preliminary findings suggest weaknesses in FDA's program for inspecting foreign drug manufacturers : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives
- Drug safety and effectiveness : issues and action options after FDA approval
- Drugmakers under siege
- FDA advisory committees : process for recruiting members and evaluating potential conflicts of interest : report to congressional requesters
- FDA's mammography inspections : while some problems need attention, facility compliance is growing : report to congressional committees
- 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
- Federal oversight of food safety : FDA's Food Protection Plan proposes positive first steps, but capacity to carry them out is critical : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives
- Federal rulemaking : improvements needed to monitoring and evaluation of rules development as well as to the transparency of OMB regulatory reviews : report to the Chairman, Committee on Oversight and Government Reform, House of Representatives
- Food and Drug Administration : agency complied with statutory requirement to reexamine condom labels
- Food and Drug Administration : approval and oversight of the drug Mifeprex : report to congressional requesters
- Food and Drug Administration : better coordination could enhance efforts to address economic adulteration and protect the public health : report to congressional requesters
- Food and Drug Administration : decision process to deny initial application for over-the-counter marketing of the emergency contraceptive drug Plan B was unusual : report to congressional requesters
- 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
- Food and Drug Administration : overseas offices have taken steps to help ensure import safety, but more long-term planning is needed : report to the Committee on Oversight and Government Reform, House of Representatives
- Food and Drug Administration : regulation of tobacco products : report to Congressional requesters
- Food and Drug Administration : response to heparin contamination helped protect public health; controls that were needed for working with external entities were recently added : report to the Ranking Member, Committee on Energy and Commerce, House of Representatives
- Food and Drug Administration : revenue information on certain companies participating in the Medical Device User Fee Program
- Food and Drug Administration's Critical Path Initiative : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Tenth Congress, first session, special hearing, June 1, 2007, Salt Lake City, Utah
- Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C
- Food irradiation : FDA could improve its documentation and communication of key decisions on food irradiation petitions
- Food labeling : FDA needs to better leverage resources, improve oversight, and effectively use available data to help consumers select healthy foods : report to the Chair, Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations, House of Representatives
- Food labeling : FDA needs to reassess its approach to protecting consumers from false or misleading claims : report to congressional committees
- Food safety : FDA could strengthen oversight of imported food by improving enforcement and seeking additional authorities : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives
- Food safety : FDA needs to reassess its approach to reducing an illness caused by eating raw oysters : report to the Honorable Rosa L. DeLauro, House of Representatives
- Food safety : FDA should strengthen Its oversight of food ingredients determined to be Generally Recognized as Safe (GRAS) : report to congressional requesters
- Food safety : agencies need to address gaps in enforcement and collaboration to enhance safety of imported food : report to congressional committees
- Food safety : federal efforts to ensure imported food safety are inconsistent and unreliable: statement of Robert E. Robertson, Associate Director, Food and Agriculture Issues, Resources, Community, and Economic Development Division, before the Permanent Subcommittee on Investigations, Committee on Governmental Affairs, U.S. Senate
- Food safety : foodborne illness and selected recalls of FDA-regulated foods
- Food safety : improvements needed in FDA oversight of fresh produce : report to congressional requesters
- Innovation in America : opportunities and obstacles : hearing before the Subcommittee on Competitiveness, Innovation, and Export Promotion of the Committee on Commerce, Science, and Transportation, United States Senate, One Hundred Eleventh Congress, second session, June 22, 2010
- Mad cow disease : an evaluation of a small feed testing program FDA implemented in 2003 with recommendations for making the program a better oversight tool
- Medical devices : European Union's regulatory process
- Medical devices : FDA review times, 1989 through 1996
- Medical devices : FDA's approval of four temporomandibular joint implants : report to congressional requesters
- 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
- Medical devices : shortcomings in FDA's premarket review, postmarket surveillance, and inspections of device manufacturing establishments : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives
- Medical readiness : safety and efficacy of the anthrax vaccine : statement of Kwai-Cheung Chan, Director, Special Studies and Evaluations, National Security and International Affairs Division, before the Subcommittee on National Security, Veterans' Affairs, and International Relations, Committee on Government Reform, House of Representatives
- Prescription drugs : FDA guidance and regulations related to data on elderly persons in clinical drug trials
- Prescription drugs : FDA has met most performance goals for reviewing applications : report to congressional requesters
- Prescription drugs : FDA's oversight of the promotion of drugs for off-label uses : report to the Ranking Member, Committee on Finance, U.S. Senate
- Reprocessed single-use medical devices : FDA oversight has increased, and available information does not indicate that use presents an elevated health risk : report to the Committee on Oversight and Government Reform, House of Representatives
- Seafood fraud : FDA program changes and better collaboration among key federal agencies could improve detection and prevention : report to the Ranking Member, Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard, Committee on Commerce, Science, and Transportation, U.S. Senate
- Year 2000 computing crisis: readiness of Medicare and the health care sector: : testimony before the Subcommittee on Oversight and Investigations and the Subcommittee on Health and Environment, Committee on Commerce, House of Representatives
- Your guide to reporting problems to FDA
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