Balancing US patent and FDA approval processes: strategically optimizing market exclusivity.
Fernandez
Dennis S
DS
Fernandez and Associates L.L.P., 1047 El Camino Real, Suite 201, Menlo Park, CA 94025, USA. dennis@iploft.com
Huie
James T
JT
D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000191:economics; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D015507:Drugs, Investigational