[ Price : $8.95]
NOTUS reports that FDA will reorganize on 10/1 to a shared services model in which administrative functions are centralized, and i...[ Price : $8.95]
A BioProcess International column says drug companies should design a controlled evidence ecosystem that can demonstrate to FDA in...[ Price : $8.95]
Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's misleading...[ Price : $8.95]
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with t...[ Price : $8.95]
An FDA final guidance encourages sponsors of oncology clinical trials to broaden eligibility criteria by including more patients w...[ Price : $8.95]
FDA reviewers raise issues with Capricor Therapeutics resubmitted deramiocel for treating cardiomyopathy in male patients with Duc...[ Price : $8.95]
FDA encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomita...[ Price : $8.95]
A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unn...