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Australia’s Therapeutic Goods Administration is proposing expedited drug application reviews that would mirror programs in North America and Europe. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More
Industry is asking the FDA to impose stricter requirements for outsourcing facilities to qualify for an exemption that allows them to produce near replicas of approved products. Read More
The FDA’s Office of Generic Drugs is going to focus on meeting its scientific priorities from previous years, instead of setting out to accomplish new projects for this fiscal year – the final year of the five-year authorization for GDUFA. Read More