180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications; Proposed rule; withdrawal (01NOV02)
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Guidance for Industry on Immunotoxicology Evaluation of Investigational New Drugs; Availability. (01NOV02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Investigational New Drug Regulations.
(18OCT02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Regulations.
(22JUL02)
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Human drugs: Unapproved new investigational drug products; export requirements. GPO Correction. (05JUL02)
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Guidance for Industry on Providing Regulatory Submissions in Electronic Format- ANDAs; Availability. (27JUN02)
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Investigational New Drugs: Export Requirements for Unapproved New Drug Products. (19JUN02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Temporary Marketing Permit
Applications. (30MAY02)
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Draft Guidance for Industry on Topical Dermatological Drug Product NDAs and ANDAs--In Vivo Bioavailability,
Bioequivalence, In Vitro Release and Associated Studies; Withdrawal. (17MAY02)
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An FDA/Industry Dialog on the Application Submission Process; Public Workshop. (03MAY02)
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Agency Information Collection Activities; Announcement of OMB Approval; Application for FDA Approval to Market a New Drug.
(30APR02)
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Supporting Statement |
Novartis Pharmaceuticals Corp et al.; Withdrawal of Approval of 38 New Drug Applications. (29APR02)
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Draft Guidance for Industry on Exposure-Response Relationships: Study Design, Data Analysis, and Regulatory Applications;
Availability. (02APR02)
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Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational New Drug
Applications IINDs); Availability.
(29MAR02)
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