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FDA Guidance Documents Update Nov. 2015 on Devices, Animal Studies, Gene Therapy, Liposomes

Posted in FDA, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Lipidomics, Liposome, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Uncategorized, tagged , , , , , on November 3, 2015| Leave a Comment »

 

FDA Guidance Documents Update

Reporter: Stephen J. Williams, Ph.D.
10/30/2015
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Recently posted guidance documents

10/14/15: General Considerations for Animal Studies for Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff

10/14/15: Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry

10/15/15: Draft PDEs for Triethylamine and for Methylisobutylketone

10/15/15: ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents

10/19/15: CVM GFI #229 – Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle

10/21/15: Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use

10/21/15: Manufacturing Site Change Supplements: Content and Submission – Draft Guidance for Industry and Food and Drug Administration Staff

10/26/15: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

10/26/15: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act

10/26/15: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance

10/27/15: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route

10/27/15: Product Development Under the Animal Rule

10/28/15: DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry

10/29/15: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation

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Liver on the chip devices with the capacity to replace animal experiments

Posted in Biomarkers & Medical Diagnostics, Organ-on-a-Chip, tagged , , , , , on October 23, 2015| Leave a Comment »

Liver on the chip devices with the capacity to replace animal experiments

Reporter: Irina Robu, PhD

In the recent years, there is a growing perception that animal experiments fail to predict human responses which indicates the development of other models to predict drug toxicity. The main challenge in replacing animal experiments is that the human cells have a low survival rate when they are outside the body. Researchers at Hebrew University of Jerusalem and the Fraunhofer Institute for Cell Therapy and Immunology in Germany partnered to create a liver-on-chip device mimicking human physiology. In addition , they use nanotechnology based sensors to the living tissue to identify toxicity.

The results indicated he first discovery of a new toxicity mechanism using the newly emerging human-on-a-chip technology which indicates development of alternative models of animal testing is not far away from being a reality. The market for this technology shows a double digit annual growth rate in the last 3 years and is estimated to
grow to $17 billion by 2018.
 
Source
http://www.innovationtoronto.com/2015/08/israeli-german-partnership-aims-to-replace-animal-experiments-with-advanced-liver-on-chip-devices/

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