FDA Guidance Documents Update

Recently posted guidance documents:

7/18/16: E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)

7/18/16: E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers

7/21/16: CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals

7/26/16: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff

7/27/16: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff

7/27/16: Adaptive Designs for Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff

7/29/16: General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff

8/1/16: FY 2017 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

8/2/16: Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy; Guidance for Industry

8/3/16: Insanitary Conditions at Compounding Facilities Guidance for Industry

8/3/16: Medical X-Ray Imaging Devices Conformance with IEC Standards - Draft Guidance for Industry and Food and Drug Administration Staff

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