FDA Guidance Documents Update

Recently posted guidance documents:

8/5/16: Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry

8/8/16: Deciding When to Submit a 510(k) for a Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff

8/8/16: Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff

8/9/16: Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2016

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