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Gdufa published presentations and documents on DocSlides.

Draft Guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA

Draft Guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA

natalia-silvester
0 Slides

Overview of Presentation. Background. Discipline ...

Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only

Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only

conchita-marotz
17 Slides

Comments and suggestions regarding this draft doc...

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