Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Changes to an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). (29DEC99)
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Supporting Statement

``Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format-Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]''; Availability. (12NOV99)
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The Guidance

Agency Emergency Processing Request Under OMB Review; Guidance for Industry; Changes to an Approved NDA or ANDA. (03NOV99)
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Agency Information Collection Activities: Proposed Collection;  Comment Request; Investigational New Drug Regulations (11MAY99) Click here for txt or pdf

Investigational New Drug Applications; Clinical Holds; Confirmation of Effective Date. [TXT]  [PDF] (20APR99)
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Draft Guidance for Industry on IND's for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products; Chemistry, Manufacturing, and Controls Content and Format; Availability. [TXT] [PDF] (21APR99)
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The Guidance. Click here for pdf