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Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to quality management issues. Read More
Aspen Pharma and Deco Pharma, the company’s distributor, face disciplinary proceedings from Spain’s antitrust authority for allegedly limiting the distribution and hiking the prices of drugs. Read More
Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. 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 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