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Revised Draft Guidance for Industry: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.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Draft Guidance for Industry on De Novo Classification Process (Evaluation of Automatic Class III Designation).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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