In its report on FY 2024 approvals of medical devices for pediatric uses, FDA says that 19 of the 56 device approvals that year were indicated for use...
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...
FDA encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomitant medications.
A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to...
FDA announces an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investigational New Drug Pil...
Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's misleading GLP-1 advertising c...
