Regulator Spotlight
At the Indian Pharmaceutical Alliance (IPA) 2024 Advanced GMP Workshop held in Mumbai, India in late October, FDA India Office Director Greg Smith explained how his office’s engagement with India’s central and state regulators and with industry has deepened since the office was established 15 years ago and now includes a broad range of collaborative activities and shared learnings. He explained the importance of India to the U.S. drug supply chain and reviewed the results of the FDA inspection program there, in which Indian regulators are participating.
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ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion at a recent conference in which leading regulators address the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the featured regulator stories since IPQ began its Weekly Supplement series in February 2024. Also appended are the headlines of the in-depth stories that IPQ has released since 2020. Those of especially high relevance to the regulator insights provided in this issue are indicated with a red star. Click on the headlines to access the stories.