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Closing what it calls an “unintended loophole,” the FDA will no longer issue orphan drug designations for smaller pediatric subpopulations of more common diseases, unless certain criteria are met. Read More
The International Generic Drug Regulators Programme released guidance for quality assessors in regulatory agencies on the preparation of quality assessment reports, and noted the guidance may be useful for anyone responsible for the preparation of quality information submitted to regulatory agencies. Read More
President Trump’s nominee for the next secretary of HHS, former Eli Lilly executive Alex Azar, told the Senate’s health committee he agrees prescription drug prices are too high, and would welcome congressional action if appointed to the post. Read More
The UK government announced a long-term strategy for the nation’s industries, including a multi-billion pound initiative to boost investment in the life sciences sector. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic competition — and to clear the decks of older regulations that advances in science have made obsolete, a senior HHS official told lawmakers. Read More