With one in four medical devices incorporating some form of medical device software (MDSW), the European Council’s Medical Device Coordination Group (MDCG) has issued a guidance on the regulatory pathway…
Panacea Biotec, a maker of generic and specialty pharmaceuticals as well as vaccines, got rapped with a nine-observation Form 483 for inadequate oversight of aseptic procedures and environmental conditions for…
The proposed regulation to curb ethylene oxide (EtO) emissions would bring some surgeries and other medical procedures to a screeching halt, a medical device industry representative told a congressional subcommittee…
The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and mitigating the…
In this edition of Quick Notes, we cover another Philips ventilator recall, GE HealthCare and Novo Nordisk collaborate to develop a diabetes and obesity ultrasound treatment and 510(k) clearance for…
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…
In the latest FDA blow to Biocon Biologics, a July inspection of its insulin production facility in Johor, Malaysia, has been classified by the agency as “Official Action Indicated” (OAI),…
The European Commission (EC) has unconditionally approved Pfizer’s $43 billion acquisition of Seagen, concluding that the transaction would not raise competition concerns in the EU, Iceland, Liechtenstein and Norway. Source:…
Eli Lilly has filed lawsuits against 11 online pharmacies that are importing, selling and distributing products purported to contain the active ingredient Lilly’s blockbuster glucagon-like peptide-1 (GLP-1) receptor agonist Mounjaro…
Over the past week, the FDA issued final guidances on testing for methanol in alcohol, premarket notification for magnetic resonance diagnostic devices, patient remote monitoring devices, benefit-risk assessments for new…