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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
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