FDA issues a guidance to help applicants develop labeling information demonstrating the connection between antihypertensive drugs and improved cardiov...
Stakeholders generally support the FDA position on clinical immunogenicity studies for biosimilar and interchangeable insulin products.
CDER issues a list of 80 new and revised draft guidances it plans to publish in 2020.
FDA revises the CDER MAPP dealing with the review of ANDAs, amendments, and supplements.
FDA denies a Public Citizen petition seeking a narrower indication and labeling changes for Vanda's Hetlioz sleep disorder drug.
The California Superior Court orders Johnson & Johnson to pay $343.99 million in penalties for false and deceptive marketing of its pelvic mesh produc...
FDA warns R&B Medical Group about HCT/P deviations in its work as a contract testing laboratory.
Federal Register notice: FDA requests nominations for voting members to serve on CDRHֺֺs Patient Engagement Advisory Committee.