The biotech company said requests for remdesivir overwhelmed its emergency treatment access system. Consequently, it plans to rapidly implement expanded access programs.
FDA commissioner gives clues of agency's right-to-try strategy in Q&A session during chat with BIO President Jim Greenwood.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The FDA is simplifying its compassionate use process, aiming to make it easier for terminally ill patients to access potentially life-saving drugs, reports Alexander Gaffney over at RAPS. This could have some rather interesting implications for the life sciences industry – companies and regulators alike, Gaffney said, are actually concerned by this change in plans. It could […]
The ethical minefield surrounding the FDA’s compassionate use application process was front page news in 2014. The debate over who gets access to new and experimental treatments when all other options have run out for people with terminal illnesses or debilitating diseases spawned a social media campaign that led to a media firestorm. This led […]