CDRH set a new record last year, says its latest annual report, granting marketing authorization to 124 novel devices, excluding emergency use authorizations (EUAs), the highest in the more than…
The FDA has warned Novartis that its direct to consumer TV ad for its breast cancer drug Kisqali (ribociclib) makes false or misleading representations about the drug’s efficacy, sending the…
CMS and the FDA have issued a rare joint statement advocating for the oversight of laboratory developed tests (LDT) by both agencies, rather than keeping it solely within CMS. Source:…
Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Source: Drug Industry Daily
High drug prices and barriers to generic drugs are the targets of Sens. Amy Klobuchar (D-Minn.) and Bernie Sanders (I-Vt.) who are seeking answers from pharmaceutical manufacturers. Source: Drug Industry…
Federal watchdog the General Accounting Office (GAO) will be investigating the FDA and its oversight of medical device recalls, highlighted by health crises related to Philips Respironics’ ventilators and CPAP…
Over the past week, the FDA issued final guidance on drug security at the package level and announced a meeting of the medical imaging drugs advisory committee. Source: Drug Industry…
Senator Thom Tillis (R-N.C.) has warned the Biden Administration its invoking of a controversial policy framework that allows the government to access patents developed using federal funds will stop innovation…
Building on the experience of other EU alliances that address major industrial challenges, the European Commission (EC) plans to bring together drugmakers, regulators, and civil representatives to address persistent drug…
In a decline from its 89 approvals in 2022, the European Medicines Agency (EMA) recommended marketing authorizations for 77 human drugs in 2023, including 39 new active substances, 17 orphan…