Under the new pathway, the FDA is expected to allow developers of such drugs to conduct smaller, faster clinical trials and provide a "special medical use" label enabling doctors to administer drugs to critical patients.
The FDA plans have been revealed by its commissioner Margaret Hamburg.
Pew Health Group medical programs deputy director Allan Coukell said a pathway that would allow products to come to market faster and also ensuring they were used only in patients where there was an applicable risk-benefit situation would be good.
"It would be good for developers, for companies and it would be good for public health," Coukell added.