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The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislation package due by the end of September. Read More
The EMA published a third revision to its guideline for human normal immunoglobulin for intravenous use, covering biological data, pharmacokinetics, clinical trials and patient follow-up, as well as changes in the manufacturing process of previously authorized products. Read More
China’s Food and Drug Administration recently proposed revisions to its good clinical practices guidelines, standardizing the conduct of drug studies. According to the global law firm Ropes & Gray, the revisions are similar to those proposed by the International Conference on Harmonization guidelines. Read More
When instituting electronic informed consent processes, sponsors should present study information in an easily understandable manner and ensure that documentation is legally effective, according to guidance from the FDA and the HHS Office of Human Research Protections. Read More
The FDA is providing industry with a list of examples of product communications, including promotional materials, consistent with the agency-approved labeling. Read More