Human Drugs
FDA Funding Rare Disease Data Platform Meeting
FDA funds a meeting to launch a new rare disease data analytics platform.
Medical Devices
NvisionVLE Imaging System OKd for Pancreas/Bile Duct
FDA clears a NinePoint Medical for the NvisionVLE Imaging System for use in the pancreas and bile duct.
Human Drugs
FDA Should Address Approval Rate Factors: GAO
The Government Accountability Office suggests ways in which FDA could address factors that restrict generic drug first review cycle approvals.
Human Drugs
Blueprint NDA Gets Priority Review for Avapritinib
FDA accepts for priority review a Blueprint Medicines NDA for avapritinib for treating adult patients with PDGFRA Exon 18 mutant gastrointestinal stro...
Medical Devices
FDA Seeks Computational Heart Modeling Software
FDA looks for potential vendors to perform whole heart simulations and studies.
Human Drugs
Grassley Wants Unannounced Foreign Drug Inspections
Sen. Grassley asks FDA to resume unannounced inspections at foreign drug manufacturing facilities.
Human Drugs
Fabry Disease Drug Development Guidance
FDA issues a draft guidance on developing drugs to treat Fabry Disease.
FDA to Research Provider Boxed Warning Perceptions
CDERs Office of Prescription Drug Promotion says it will survey healthcare providers to learn how they receive, process, and use Boxed Warning and oth...
Marketing
Healthcare Providers Value Reprints: Report
A CMI Media doctor survey shows that providers want to receive current medical news and clinical information and can access a variety of media.
Federal Register
Nonvoting Member Needed on CBER Vaccine Panel
Federal Register notice: FDA seeks interested industry organizations to participate in selecting a nonvoting industry representative to serve on CBER ...
