The VGDS model divides data into three submission categories: "known biomarker," "probable biomarker" and "exploratory or research data." Within each category, separate guidelines apply to investigational new drugs (INDs), new NDAs/BLAs, and existing NDAs/BLAs.
ASCO American Society of Clinical Oncology * BLAs Biological License Applications * EGFR Epidermal Growth Factor Receptor Inhibitor * EMEA European Medicines Agency * ER Estrogen Receptor * HER-2 Human Epidermal Growth Factor Receptor 2 * IND Investigational New Drug * NDAs New Drug Applications * OECD Organization for Economic Co-Operation and Development * PARP Poly (ADP-ribose) Polymerase * PR Progesterone Receptor * SNPs Single-Nucleotide Polymorphisms * USFDA United States Food and Drug Administration * VGDS Voluntary Genomic Data Submission Program
They may be reached at editor@ScientificComputing.com Table 1: The VGDS Model IND NEW NDA/BLA EXISTING NDA/BLA Known 21CFR 312.23 21CFR 314.50 21CFR 314.81 Biomarker (a)(8)(9)(10) and 601.2 annual (iv) or (11) Probable voluntary recommended 21 CFR 314.81 Biomarker annual Exploratory/ voluntary recommended voluntary Research Data
Whether the requirement is from a small regional airfield or a large international airport, ASM's VGDS modular approach means that the docking system can 'grow' with the requirements of operators of all sizes.
The VGDS is a passive system that combines the well proven signal format of AGNIS and PAPA with the latest wide angle, high intensity LED technology, to ensure clear stand centreline guidance and stopping information on one easily-interpreted display.
ASM's Single and Dual Pilot Display VGDS is fully compliant with ICAO Annex 14 Volume I Fourth Edition July 2004.