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British Prime Minister Theresa May wants to strike a deal with the UK’s life sciences industry to increase the sector’s productivity and maximize the country’s investment in research and development. Read More
The International Council on Harmonization is proposing to expand guidance concerning data quality, medication errors and product issues by developing a companion document that would include a Q&A section and more examples. Read More
The FDA finalized guidance on the GMP requirements for combination products, adding scenarios to clarify how manufacturers can comply with requirements. Read More
More than 160 biotech executives, investors and researchers signed a letter opposing President Trump’s executive order restricting immigration from seven Middle Eastern and African nations. Read More
Former FDA deputy commissioner Scott Gottlieb emerged as the favorite to serve as the next FDA commissioner in a survey of 53 pharmaceutical companies. Read More
The FDA has made great strides in conducting international inspections — but still remains detrimentally understaffed, according to the government’s official watchdog, during a time when the agency has begun to inspect more sites overseas than within the U.S. Read More
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 legislative package due by the end of September. Read More
The European Parliament’s committee on Environment, Public Health and Food Safety voted to approve a draft report that includes dozens of recommendations for improving how the EU promotes access to medicine and handles safety, intellectual property, and pricing issues. Read More
The Office of Management and Budget clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over $100 million per year, and new guidance documents considered on a case-by-case basis. Read More