| aBLA |
abbreviated biologics license application |
| AIA |
Leahy–Smith America Invents Act |
| ANDA |
abbreviated new drug application |
| BLA |
biologics license application |
| BPCI Act |
Biologics Price Competition and Innovation Act |
| CBER |
Center for Biologics Evaluation and Research |
| CDA |
confidentiality agreement |
| CDER |
Center for Drug Evaluation and Research |
| CFR |
Code of Federal Regulations |
| CI exclusivity |
clinical investigation exclusivity |
| CIP application |
continuation-in-part application |
| EMA |
European Medicines Agency |
| FDA |
U.S. Food and Drug Administration |
| FDCA |
U.S. Federal Food, Drug, and Cosmetic Act |
| Federal Circuit |
U.S. Court of Appeals for the Federal Circuit |
| FTO opinion |
freedom-to-operate opinion |
| IND |
investigational new drug application |
| MPEP |
Manual of Patent Examining Procedure |
| MTA |
material transfer agreement |
| NCE exclusivity |
new chemical entity exclusivity |
| NDA |
new drug application, nondisclosure agreement |
| Orange Book |
The FDA database titled Approved Drug Products with Therapeutic Equivalence Evaluations |
| Patent Office |
U.S. Patent and Trademark Office |
| PCT |
Patent Cooperation Treaty |
| RLD |
reference listed drug |
| U.S.C. |
United States Code |
| USDA–APHIS |
U.S. Department of Agriculture’s Animal and Plant Health Inspection Service |
| WIPO |
World Intellectual Property Organization |