FDA Guidance Documents Update

Recently posted guidance documents:

11/24/15: Certification Process of Designated Medical Gases

12/1/15: CVM GFI #197 Documenting Statistical Analysis Programs and Data Files

12/1/15: CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a NAD for use in Companion Animals

12/1/15: CVM GFI #233 Veterinary Feed Directive Common Format Questions and Answers

12/3/15: Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry

12/3/15: eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff

12/4/15: Best Practices for Communication Between IND Sponsors and FDA During Drug Development

12/9/15: Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Guidance for Industry and Food and Drug Administration Staff

12/14/15: Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for Industry

12/15/15: Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Guidance for Industry and Food and Drug Administration Staff

12/15/15: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry

12/16/15: Safety Assessment for IND Safety Reporting Guidance for Industry

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