FDA grapples with gray areas in fast-tracking experimental drugs
Gray areas create agonizing conundrums for agency officials and patient advocates.
Experimental Ebola treatment given to Americans, but when will regulatory pathway extend to sick Africans?
The two Ebola-infected Americans recently evacuated from Liberia were given an experimental drug that probably saved their lives, but Popular Science raises an interesting point – no Africans are likely to get the same treatment. Not anytime soon, that is. Kent Brantly and Nancy Writebol, the two volunteers in an Ebola clinic that contracted the deadly virus, […]
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.