Module 3 - Strategic case studies in practice

ATTACHMENT D

ABBREVIATIONS

AAO American Academy of Ophthalmology ANDA Abbreviated New Drug Application BLA Biologics License Application CBER

Center for Biologics Evaluation and Research Center for Drug Evaluation and Research

CDER

CFR Code of Federal Regulations CFSAN Center for Food Safety and Applied Nutrition CGMP Current Good Manufacturing Practice CMC Chemistry, Manufacturing, and Control COA Certificate of Analysis CPSC Consumer Product Safety Commission DMF Drug Master File DPI Dry Powder Inhaler FDA U.S. Food and Drug Administration (the Agency) HDPE High Density Polyethylene IND Investigational New Drug Application LDPE Low Density Polyethylene LOA Letter of Authorization LVP Large-Volume Parenteral MDI Metered Dose Inhaler NDA New Drug Application PET Polyethylene Terephthalate PETG Polyethylene Terephthalate G PP Polypropylene PVC Polyvinyl Chloride QA Quality Assurance QC Quality Control SVP Small-Volume Parenteral USP/NF U.S. Pharmacopeia/National Formulary

D-1