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The European Medicines Agency’s EudraVigilance system for monitoring adverse events is undergoing an overhaul to comply with new postmarketing clinical trials legislation, and regulators are readying drugmakers and national authorities for a new plan. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that the drug bound to about half of the oral medications tested. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that drug bound to about half of the oral medications tested. Read More
Led by complaints about plaque psoriasis drugs, the FDA Adverse Event Reporting System recorded 205,389 primary suspect adverse event reports for 2,038 drugs in the second quarter of 2015, according to a new report by Advera Health Analytics. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
The FDA is warning healthcare providers and patients not to use sterile drugs made by an Oklahoma compounder after the firm refused to cease sterile operations following a failed inspection — the latest in a stream of safety alerts, warning letters and Form 483s having to do with compounders’ sterility practices over the past year. Read More
Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher in the U.S. will now pay a $2.7 million fee — a $165,000 increase over fiscal year 2015, which ended Sept. 30. Read More