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The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More
An FDA advisory committee deadlocked 6 to 6 on whether the benefits of a Pfizer drug treatment for recurrent renal cell carcinoma outweighed the risks. Read More
More than a dozen pharmaceutical industry leaders agreed to work together to develop new painkillers without the harmful addictive effects of opioid medicines — and to use the NIH as a central clearinghouse for research to speed up product development. Read More
To help relieve uncertainty among sponsors about its role in regulatory decisions, the FDA will publish guidance on its application of real-world evidence to drug approvals and post-market evaluations, FDA Commissioner Scott Gottlieb told the National Academy of Sciences. Read More
A federal judge signed off on a $15 million settlement to close out claims of anticompetitive behavior by Allergan and its subsidiary Warner Chilcott. Read More
A federal judge in Pennsylvania threw out AbbVie’s patent suits against generic competitors, strengthening the Federal Trade Commission’s pay-for-delay case against the drugmaker. Read More
The FDA posted only 60 ANDA approvals in August — slightly below the year’s monthly average of 63 — plus 17 tentative approvals, an overall dip after a strong showing the previous three months. Read More