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Two years after issuing guidance on data capture from electronic health records, the FDA’s Center for Drug Evaluation and Research is calling on stakeholders to help demonstrate how the use of electronic source data can help to streamline the clinical trial process. Read More
The FDA plans to investigate how well people who have suffered hearing loss — specifically older adults — are able to understand the risk information in TV drug ads. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More
A panel of experts in Australia is recommending that the government establish three new drug approval pathways to expedite listing on the Australian Register of Therapeutic Goods and speed novel treatments to patients. Read More
The Canadian government plans to require mandatory reporting of drug shortages, in a move that will bring it in line with U.S. and European shortages policies. Read More
The amount of sodium contained as an excipient in drugs should be readily available in an understandable format on product labels and package leaflets, the European Medicines Agency says. Read More
The House Appropriations Committee is proposing $2.6 billion in new funding for the FDA, roughly $200 million less than President Barack Obama requested, but no changes to the administration’s proposed user fee levels for drugs and biologics — which total about $1.2 billion. Read More
Drugmakers under consent decrees with the FDA may be able to deduct some payments made as part of their settlement with the agency when they file their tax returns, according to an informal opinion by the Internal Revenue Service’s chief counsel. Read More
The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More