FDA releases the form FDA-483 with three observations from an inspection at the Novel Laboratories (Lupin) drug manufacturing facility in Somerset, NJ...
NOTUS reports that FDA will reorganize on 10/1 to a shared services model in which administrative functions are centralized, and inspectors are genera...
A BioProcess International column says drug companies should design a controlled evidence ecosystem that can demonstrate to FDA inspectors that data t...
Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's misleading GLP-1 advertising c...
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well befor...
An FDA final guidance encourages sponsors of oncology clinical trials to broaden eligibility criteria by including more patients with reduced performa...
FDA reviewers raise issues with Capricor Therapeutics resubmitted deramiocel for treating cardiomyopathy in male patients with Duchenne muscular dystr...
FDA encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomitant medications.
