Draft ``Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis;''
Availability. (20DEC00)
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Draft Guidance |
Draft Guidance for Industry on Labeling OTC Human Drug Products-Submitting Requests for Exemptions and Deferrals;
Availability. (19DEC00)
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Draft Guidance |
Guidance for Industry on Labeling Over-the-Counter Human Drug Products Using a Column Format; Availabiliy. (19DEC00)
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The Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; OTC Test Sample Collection Systems for
Drugs of Abuse Testing. (16NOV00)
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Joint Meeting of the Nonprescription Drugs Advisory committee and the Gastrointestinal Drugs Advisory Committee; Notice of
Meeting. (30AUG00)
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Nonprescription Drugs Advisory Committee; Notice of Meeting. (30AUG00)
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Topical Antifungal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph. (29AUG00)
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Topical Otic Drug Products for Over-the-Counter Human Use; Products for Drying Water-Clogged Ears;Amendment of Monograph;Lift of
Partial Stay of Effective Date. (10AUG00)
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Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Final
Monograph for OTC Antitussive Drug Products.
(01AUG00)
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Ophthalmic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph. (21JUN00)
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Over-the-Counter Human Drugs; Labeling Requirements; Partial Extension of Compliance Dates. (20JUN00)
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Nonprescription Drugs Advisory Committee; Notice of Meeting. (20JUN00)
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Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Extension of Effective Date; Reopening of
Administrative Record. (08JUN00)
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Joint Meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory
Committee; Notice of Meeting. (01JUN00)
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Over-the-Counter Drug Products; Public Hearing. (27APR00)
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Hematology and Pathology Devices; Reclassification; Restricted Devices; OTC Test Sample Collection Systems for Drugs of
Abuse Testing. (07APR00)
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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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Guidance for Industry on Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the
Federal Food, Drug, and Cosmetic Act; Availability. (30MAR00)
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The Guidance |
Draft Guidance for Industry on OTC Treatment of Herpes Labialis With Antiviral Agents; Availability. (08MAR00)
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The Draft Guidance |
Over-The-Counter Human Drugs; Labeling Requirements; Final Rule; Technical Amendment. (03JAN00)
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