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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
Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics (PK) and pharmacodynamics (PD). Read More
The FDA rejected Adapt Pharma’s request to raise the standards for the approval of naloxone generics, arguing that products will be reviewed on a case by case basis. Read More
UK’s antitrust agency has accused Actavis of breaching competition law by raising the price of generic hydrocortisone tablets for Addison’s disease by more than 12,000 percent since 2008. Read More
Generic approvals and rejections were little changed from November, remaining stable as ANDAs slightly fell in the second month of fiscal 2017. Read More