Guidance for Industry on Labeling Over-the-Counter Human Drug Products--Updating Labeling in Reference Listed Drugs and
Abbreviated New Drug Applications; Availability.
(18OCT02)
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The Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; Extralabel Drug Use in Animals. (16OCT02)
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Supporting Statement |
Agency Information Collection Activities; Proposed Collection; Comment Request: Consumer Surveys on Food and Dietary
Supplement Labeling Issues (02OCT02)
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Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the
Tentative Final Monograph, and Related Labeling.
(21AUG02)
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Draft Guidance for Industry on Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and
Bioavailability; and Labeling Documentation; Availability. (21AUG02)
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The Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; Labeling Requirements for Color Additives (Other
Than Hair Dyes) and Petitions. (19AUG02)
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Supporting Statement |
FDA Food Labeling and Allergen Declaration; Public Workshop; Correction. (02AUG02)
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Withdrawal of 53 Guidances on Individual Product Labeling. (05JUL02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labeling Requirements for Color
Additives (other than Hair Dyes) and Petitions. (14JUN02)
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Agency Information Collection Activities; Announcement of OMB Approval; Medical Device Labeling Regulations. (16APR02)
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Over-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Dates. (05APR02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Color Additives
(Other Than Hair Dyes) and Petitions; Correction. (29MAR02)
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FDA Food Labeling and Allergen Declaration; Public Workshop. (29MAR02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Color Additives
(Other Than Hair Dyes) and Petitions.
(28FEB02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Format and Content Requirements for
Over-the-Counter (OTC) Drug Product Labeling.
(26FEB02)
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Agency Emergency Processing Request Under OMB Review; Consumer Surveys on Food and Dietary Supplement Labeling Issues.
(21FEB02)
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Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs. (01FEB02)
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