Three Hogan Lovells attorneys predict an increase in FDA enforcement action against health-related claims in product labeling.
Panelists at a virtual digital health conference say FDA enforcement discretion in their arena is ambiguous.
The Biden Administration shifts in its consideration of both acting commissioner Janet Woodcock and former FDA principal deputy commissioner Joshua Sh...
FDA says it is allowing undiluted frozen vials of the Pfizer-BioNTech Covid-19 Vaccine to be transported and stored at conventional temperatures commo...
Federal Register notice: FDA amends its animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications due to lac...
FDA approves an AbbVie supplemental BLA for Humira (adalimumab) for treating moderately to severely active ulcerative colitis in pediatric patients fi...
CDRH Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel updates the number of authorized Covid-19 tests and sample collecti...
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Humanitarian Use Devices (HUD) 21 CFR Part 81...