Summary: ZOLL Medical Corp is updating use instructions for the 731 Series Ventilator family due to missing MRI safety information, which could lead to misuse and ventilator failure. The operator’s and quick reference guides lacked details on the required distance from the MRI … [Read more...]
FDA Rejects Petition Challenging Safety of Narcolepsy Drug Wakix
Summary: The FDA has denied a citizen petition filed by a short seller challenging the safety and effectiveness of Wakix (pitolisant) for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA reaffirmed Wakix’s favorable benefit-risk profile and … [Read more...]
Melatonin Makers Urged to Follow New Safety, Labeling Guidelines
Summary: The Council for Accountable Diet (CRN) has introduced new voluntary rules for melatonin health supplements promoted for snooze help, emphasizing baby-deterrent packaging and clearer labeling, to improve shopper basic safety. These tips deal with difficulties these types … [Read more...]
Melatonin Makers Urged to Follow New Safety, Labeling Guidelines
Summary: The Council for Liable Nutrition (CRN) has launched new voluntary pointers for melatonin health supplements promoted for rest support, emphasizing boy or girl-deterrent packaging and clearer labeling, to greatly enhance shopper security. These rules deal with … [Read more...]