FDA Guidance Documents Update

Recently posted guidance documents:

11/6/15: Guidance for Industry: Questions and Answers on FDA’s Fortification Policy

11/16/15: Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use

11/17/15: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants

11/17/15: Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection - Draft Guideline for Industry and Food and Drug Administration Staff

11/19/15: Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon

11/20/15: Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act

11/20/15: Over-the-Counter Sunscreens: Safety and Effectiveness Data Guidance for Industry

11/20/15: Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process

11/20/15: Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry

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