Enable Injections, Inc. (“Enable”), a company developing and manufacturing the enFuse® platform of investigational wearable ...
The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated ...
Despite the pace of innovation in healthcare today, underrepresented populations across America are not receiving optimal ...
In coming years, the number of procedures using robotics and surgical navigation is predicted to increase at a double-digit ...
Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and ...
Staffing plans for complex generics and other FDA priorities may be complicated by the continual burden of the coronavirus ...
The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the ...
Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of ...
While US biosimilar approvals have been somewhat thin on the ground in 2021 – with the pandemic driving inspection related delays for multiple products – there were nevertheless several firsts this ...