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The European Commission says it does not have the power to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More
The FDA Monday published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More
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