International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New
Drug Substances and New Drug Products: Chemical Substances. (29DEC00)
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Electronic Investigational New Drug Application: Cumulative Table of Contents; Public Meeting. (29DEC00)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry; Changes to an
Approved NDA or ANDA. (21DEC00)
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Draft Guidance for Industry on Cancer Drug and Biological Products--Clinical Data in Marketing Applications; Availability.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The Draft Guidance |
Applications for FDA Approval to Market a New Drug; Proposed Revision of Postmarketing Reporting Requirements. (07NOV00)
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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 |
Lilly Research Laboratories et al.; Withdrawal of Approval of 28 New Drug Applications. (13SEP00)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Changes to an
Approved NDA or ANDA. (07SEP00)
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Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy;Drug Efficacy Study Implementation;
Caramiphen Edisylate; Final Actions on Supplemental New Drug Applications. (07JUL00)
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The FDA Review Process for New Product Applications: an Interactive Workshop. (05JUL00)
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Agency Information Collection Activities; Announcement of OMB Approval; Changes to an Approved NDA or ANDA. (05JUN00)
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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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The Future of the International Conference on Harmonization of Technical Requirements for the Registration of
Pharmaceuticals for Human Use (ICH); Notice of Public Meeting. (04MAY00)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry: Changes to an
Approved NDA or ANDA. (07APR00)
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John J. Ferrante et al.; Proposal to Withdraw Approval of 158 Abbreviated New Drug Applications; Opportunity for a
Hearing. (28MAR00)
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Lilly Research Laboratories et al.; Withdrawal of Approval of 22 New Drug Applications and 36 Abbreviated New Drug
Applications. (20MAR00)
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Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications
for Certain Positron Emission Tomography Drug Products; Availability (10MAR00)
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The Draft Guidance
Attachment 1
Attachment 2
Attachment 3
Attachment 4 |
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Changes to
an Approved Application, Labeling, and Revocation and Suspension. (07MAR00)
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Guidance for Industry on NDAs: Impurities in Drug Substances (25FEB00)
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The Guidance |
Draft Guidance for Industry on IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls
Information; Availability. (04FEB00)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Application to Market a New Drug,
Biologic, or an Antibiotic Drug for Human Use_Form FDA 356h. (02FEB00)
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Plans to Develop Guidance on Submitting an Archival Copy of an ANDA in Electronic Format; Request for Comments.
(27JAN00)
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New Drug Applications; Drug Master Files. (12JAN00)
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