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FDANonrulemakingFDA-2009-D-0461

Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

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Jan 5, 2023
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closed 3151d ago
National Association of Chain Drug Stores filings
3

Activity

National Association of Chain Drug Stores filed 3 comments on this docket between Dec 23, 2009 and Dec 12, 2017. 19 other organizations filed here. The comment window closed 3151d ago.

What National Association of Chain Drug Stores filed (3)

Dec 12, 2017· Comment from National Association of Chain Drug Stores (NACDS)· FDA-2009-D-0461-0094

Please see the attached comments from the National Association of Chain Drug Stores regarding the revised draft guidance on the "Format and Content of a REMS Document." We appreciate FDA considering our input on this matter.

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Aug 27, 2010· National Association of Chain Drug Stores (NACDS) - Comment· FDA-2009-D-0461-0045

Filed on regulations.gov — full text not in the inline record.

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Dec 23, 2009· National Association of Chain Drug Stores - Comment· FDA-2009-D-0461-0007

Filed on regulations.gov — full text not in the inline record.

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Abstract

Status: OPEN

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Co-filers (19)

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Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (FDA) — National Association of Chain Drug Stores | OpenPolis