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FDA’s Office of Generic Drugs (OGD) in mid-April published its annual report, detailing the progress made by OGD in 2015. Among other accomplishments, OGD took first action on nearly 90% of their “backlogged” ANDAs and PASs – achieving that level almost a year ahead of schedule. OGD also funded nearly $35 million in research programs with the aim to improve efficient development of new generic drugs. Significant research accomplishments in 2015 included two post-approval bioequivalence studies in patients with epilepsy.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
