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 reviewers raise concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of its investigational...
FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot pedal accessories.
FDA warns Hiram, GA-based VasoCorp Inc. that it is illegally marketing misbranded unapproved new drugs.
The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative systems pharmacology...
