International Conference on Harmonisation; Guidance on E11 Clinical Investigation of Medicinal Products in the Pediatric
Population; Availability. (15DEC00)
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The Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Draft Guidance for Industry on
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank. (09NOV00)
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Draft Guidance for Industry on Cancer Drug and Biological Products--Clinical Data in Marketing Applications; Availability.
(09NOV00)
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The Draft Guidance |
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.
(03NOV00)
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Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports. (30OCT00)
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Revised Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds; Availability. (26OCT00)
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The Guidance |
Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based
Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors; Availability. (18OCT00)
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The Guidance |
Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in
Pediatric Patients; Technical Amendment. (06OCT00)
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Clinical Pharmacology During Pregnancy; Public Meeting. (04OCT00)
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Agency Information Collection Activities; Announcement of OMB Approval; Submitting and Reviewing Complete Responses to
Clinical Holds; Guidance for Industry. (03OCT00)
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Supporting Statement |
Rami Elsharaiha; Debarment Order. (29SEP00)
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Jay Marcus; Debarment Order. (29SEP00)
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Mohammad Uddin; Debarment Order. (29SEP00)
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Food and Drug Administration/Industry Exchange Conference and Workshop on Clinical Trial Requirements; Public Workshop.
(18AUG00)
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International Conference on Harmonisation; Draft Guidance on Safety Pharmacology Studies for Human Pharmaceuticals;
Availability. (07AUG00)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry: Submitting
and Reviewing Complete Responses to Clinical Holds. (05JUL00)
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Draft Guidance for Industry on Allergic Rhinitis: Clinical Development Programs for Drug Products; Availability. (21JUN00)
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The Draft Guidance |
Rajaram K. Matkari; Conviction Reversal; Final Order Terminating Debarment. (13JUN00)
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Investigational New Drug Applications; Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening
Diseases and Conditions. (01JUN00)
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Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry: Submitting and
Reviewing Complete Responses to Clinical Holds. (13APR00)
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International Conference on Harmonisation; E11: Clinical Investigation of Medicinal Products in the Pediatric Population.
(12APR00)
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Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent
Requirements for Emergency Research; Availability. (30MAR00)
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The Draft Guidance |
Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases:
Establishment of a Data Bank; Availability. (29MAR00)
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Prepublication document
The Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; New Drug and Biological Drug Products; Evidence
Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted. (18JAN00)
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Supporting Statement |
Investigational Biological Product Trials; Procedure to Monitor Clinical Hold Process; Meeting of Oversight Committee and
Request for Submissions. (05JAN00)
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