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1
Food and Drug Administration approval and oversight of the drug Mifeprex : report to congressional requesters.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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2
Medical devices FDA's approval of four temporomandibular joint implants : report to congressional requesters.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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3
FDA warning letters : timeliness and effectiveness.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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4
FDA warning letters : trends and perspectives.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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5
Prescription drugs FDA guidance and regulations related to data on elderly persons in clinical drug trials.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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6
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 Su...
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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7
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.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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8
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...
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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9
Drug safety preliminary findings suggest weaknesses in FDA's program for inspecting foreign drug manufacturers : testimony before the Subcommittee on Oversight and Investigations,...
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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10
Food and Drug Administration limited available data indicate that FDA has been meeting some goals for review of medical device applications : report to congressional committees.
Subjects: “…United States. Food and Drug Administration Rules and practice Evaluation.…”
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11
Drug safety improvement needed in FDA's postmarket decision-making and oversight process : report to congressional requesters.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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12
Drug safety FDA needs to further address shortcomings in its postmarket decision-making process : testimony before the Subcommittee on Oversight and Investigations, Committee on En...
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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13
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.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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14
An Act to Expand the Tropical Disease Product Priority Review Voucher Program to Encourage Treatments for Zika Virus.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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15
Medical devices challenges for FDA in conducting manufacturer inspections : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, Hou...
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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16
Rare diseases : expediting treatments for patients : hearing before the Subcommittee on Children and Families of the Committee on Health, Education, Labor, and Pensions, United Sta...
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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17
Antibiotics FDA needs to do more to ensure that drug labels contain up-to-date information : report to congressional committees.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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18
Drug safety better data management and more inspections are needed to strengthen FDA's foreign drug inspection program : report to congressional requesters.
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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19
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 Ov...
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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20
FDA to consider whether and how to lower permissible nicotine levels in cigarettes /
Subjects: “…United States. Food and Drug Administration Rules and practice.…”
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