ARTICLE
5 September 2014

FDA Issues The Following Guidance Documents

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Guidance for Industry on Evaluation of Sex-Specific Data in Medical Device Clinical Studies. August 22, 2014, Federal Register.
United States Food, Drugs, Healthcare, Life Sciences

Guidance for Industry on Evaluation of Sex-Specific Data in Medical Device Clinical Studies. August 22, 2014, Federal Register

Revised Draft Guidance for Industry: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format. August 14, 2014, Federal Register. Comments due October 14, 2014.

Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products. August 14, 2014, Federal Register

Draft Guidance for Industry on De Novo Classification Process (Evaluation of Automatic Class III Designation). August 14, 2014, Federal Register. Comments due October 14, 2014.

Guidance for Industry: FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations. August 19, 2014, Federal Register

Guidance for Industry: Unique Device Identification System: Frequently Asked Questions, Vol. 1. Released August 20, 2014.

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